en-usKHI is a public-private partnership established in 2012 between ASN and the US Food and Drug Administration (FDA). This partnership helps foster the development of new products to improve the lives of people living with kidney diseases. As part of the work, KHI manages <a href="https://khi.asn-online.org/projects">multiple projects with the FDA</a>. Some of the outcomes of those projects are papers published in CJASN.Mon, 06 Dec 2021 16:45:30 GMThttp://cct.highwire.org/feeds/asn/kidney-health-initiative.rsshttp://cjasn.asnjournals.org/lookup/doi/10.2215/CJN.17561120?cct=2375Cardiovascular disease is a prevalent and prognostically important comorbidity among patients with kidney disease, and individuals with kidney disease make up a sizeable proportion (30%–60%) of patients with cardiovascular disease. However, several systematic reviews of cardiovascular trials have observed that patients with kidney disease, particularly those with advanced kidney disease, are often excluded from trial participation. Thus, currently available trial data for cardiovascular interventions in patients with kidney disease may be insufficient to make recommendations on the optimal approach for many therapies. The Kidney Health Initiative, a public-private partnership between the American Society of Nephrology and the US Food and Drug Administration, convened a multidisciplinary, international work group and hosted a stakeholder workshop intended to understand and develop strategies for overcoming the challenges with involving patients with kidney disease in cardiovascular clinical trials, with a particular focus on those with advanced disease. These efforts considered perspectives from stakeholders, including academia, industry, contract research organizations, regulatory agencies, patients, and care partners. This article outlines the key challenges and potential solutions discussed during the workshop centered on the following areas for improvement: building the business case, re-examining study design and implementation, and changing the clinical trial culture in nephrology. Regulatory and financial incentives could serve to mitigate financial concerns with involving patients with kidney disease in cardiovascular trials. Concerns that their inclusion could affect efficacy or safety results could be addressed through thoughtful approaches to study design and risk mitigation strategies. Finally, there is a need for closer collaboration between nephrologists and cardiologists and systemic change within the nephrology community such that participation of patients with kidney disease in clinical trials is prioritized. Ultimately, greater participation of patients with kidney disease in cardiovascular trials will help build the evidence base to guide optimal management of cardiovascular disease for this population.10.2215/CJN.17561120Fri, 23 Apr 2021 09:43:33 GMT-07:00Understanding and Overcoming the Challenges Related to Cardiovascular Trials Involving Patients with Kidney DiseaseCardiovascular disease is a prevalent and prognostically important comorbidity among patients with kidney disease, and individuals with kidney disease make up a sizeable proportion (30%–60%) of patients with cardiovascular disease. However, several systematic reviews of cardiovascular trials have observed that patients with kidney disease, particularly those with advanced kidney disease, are often excluded from trial participation. Thus, currently available trial data for cardiovascular interventions in patients with kidney disease may be insufficient to make recommendations on the optimal approach for many therapies. The Kidney Health Initiative, a public-private partnership between the American Society of Nephrology and the US Food and Drug Administration, convened a multidisciplinary, international work group and hosted a stakeholder workshop intended to understand and develop strategies for overcoming the challenges with involving patients with kidney disease in cardiovascular clinical trials, with a particular focus on those with advanced disease. These efforts considered perspectives from stakeholders, including academia, industry, contract research organizations, regulatory agencies, patients, and care partners. This article outlines the key challenges and potential solutions discussed during the workshop centered on the following areas for improvement: building the business case, re-examining study design and implementation, and changing the clinical trial culture in nephrology. Regulatory and financial incentives could serve to mitigate financial concerns with involving patients with kidney disease in cardiovascular trials. Concerns that their inclusion could affect efficacy or safety results could be addressed through thoughtful approaches to study design and risk mitigation strategies. Finally, there is a need for closer collaboration between nephrologists and cardiologists and systemic change within the nephrology community such that participation of patients with kidney disease in clinical trials is prioritized. Ultimately, greater participation of patients with kidney disease in cardiovascular trials will help build the evidence base to guide optimal management of cardiovascular disease for this population.Ishida, Julie H.Chauhan, CynthiaGillespie, BarbaraGruchalla, KenMcCullough, Peter A.Quella, SusanRomero, AlainRossignol, PatrickWheeler, David C.Malley, Meaghan A.West, MelissaHerzog, Charles A.2021-04-23T09:43:33-07:00doi:10.2215/CJN.17561120hwp:resource-id:clinjasn;16/9/1435American Society of NephrologyCopyright © 2021 by the American Society of NephrologyClinical Journal of the American Society of Nephrologycardiovascular, kidney disease, cardiorenal, cardiovascular trialsFeatureFeatureresearch-article20212021-09-01September 202110.2215/CJN.175611201555-90411555-905X2021-04-23T09:43:33-07:002021-09Clinical Journal of the American Society of NephrologyFeature16914351444http://cjasn.asnjournals.org/lookup/doi/10.2215/CJN.16621020?cct=2375kevin.erickson@bcm.edu10.2215/CJN.16621020Mon, 12 Jul 2021 07:54:45 GMT-07:00Patient-Reported Experiences with Dialysis Care and Provider Visit FrequencyBrady, Brian M.Zhao, BoDang, Bich N.Winkelmayer, Wolfgang C.Chertow, Glenn M.Erickson, Kevin F.2021-07-12T07:54:45-07:00doi:10.2215/CJN.16621020hwp:resource-id:clinjasn;16/7/1052American Society of NephrologyCopyright © 2021 by the American Society of NephrologyClinical Journal of the American Society of Nephrologyclinical nephrology, dialysis, epidemiology and outcomesOriginal ArticlesMaintenance DialysisOriginal ArticlesMaintenance Dialysisresearch-article20212021-07-01July 202110.2215/CJN.166210201555-90411555-905X2021-07-12T07:54:45-07:002021-07Clinical Journal of the American Society of NephrologyOriginal Articles16710521060http://cjasn.asnjournals.org/lookup/doi/10.2215/CJN.11780720?cct=237510.2215/CJN.11780720Wed, 03 Mar 2021 06:28:26 GMT-08:00Legitimization and Incorporation of Patient PreferencesConway, Paul T.Knight, Richard2021-03-03T06:28:26-08:00doi:10.2215/CJN.11780720hwp:resource-id:clinjasn;16/4/645American Society of NephrologyCopyright © 2021 by the American Society of NephrologyClinical Journal of the American Society of Nephrologypatient preference information, patient insights, Kidney Precision Medicine Project, FDA, Kidney Health Initiative, KidneyX, NIH, patient engagement, advancing American kidney healthPerspectivesPerspectivesresearch-article20212021-04-07April 07, 202110.2215/CJN.117807201555-90411555-905X2021-03-03T06:28:26-08:002021-04-07Clinical Journal of the American Society of NephrologyPerspectives1644444645634636639642647635638641644http://cjasn.asnjournals.org/lookup/doi/10.2215/CJN.11540720?cct=237510.2215/CJN.11540720Thu, 15 Oct 2020 06:51:39 GMT-07:00Children with CKD Are Not Little Adults with CKDKula, Alexander J.Somers, Michael J.G.,2020-10-15T06:51:39-07:00doi:10.2215/CJN.11540720hwp:resource-id:clinjasn;16/3/470American Society of NephrologyCopyright © 2021 by the American Society of NephrologyClinical Journal of the American Society of NephrologyAAKH, pediatric nephrology, advocacy, chronic kidney disease, childrenPerspectivesPerspectivesresearch-article20212021-03-08March 08, 202110.2215/CJN.115407201555-90411555-905X2020-10-15T06:51:39-07:002021-03-08Clinical Journal of the American Society of NephrologyPerspectives163470472http://cjasn.asnjournals.org/lookup/doi/10.2215/CJN.08000520?cct=2375Enteric hyperoxaluria is a distinct entity that can occur as a result of a diverse set of gastrointestinal disorders that promote fat malabsorption. This, in turn, leads to excess absorption of dietary oxalate and increased urinary oxalate excretion. Hyperoxaluria increases the risk of kidney stones and, in more severe cases, CKD and even kidney failure. The prevalence of enteric hyperoxaluria has increased over recent decades, largely because of the increased use of malabsorptive bariatric surgical procedures for medically complicated obesity. This systematic review of enteric hyperoxaluria was completed as part of a Kidney Health Initiative–sponsored project to describe enteric hyperoxaluria pathophysiology, causes, outcomes, and therapies. Current therapeutic options are limited to correcting the underlying gastrointestinal disorder, intensive dietary modifications, and use of calcium salts to bind oxalate in the gut. Evidence for the effect of these treatments on clinically significant outcomes, including kidney stone events or CKD, is currently lacking. Thus, further research is needed to better define the precise factors that influence risk of adverse outcomes, the long-term efficacy of available treatment strategies, and to develop new therapeutic approaches.10.2215/CJN.08000520Tue, 08 Sep 2020 08:21:41 GMT-07:00Pathophysiology and Treatment of Enteric HyperoxaluriaEnteric hyperoxaluria is a distinct entity that can occur as a result of a diverse set of gastrointestinal disorders that promote fat malabsorption. This, in turn, leads to excess absorption of dietary oxalate and increased urinary oxalate excretion. Hyperoxaluria increases the risk of kidney stones and, in more severe cases, CKD and even kidney failure. The prevalence of enteric hyperoxaluria has increased over recent decades, largely because of the increased use of malabsorptive bariatric surgical procedures for medically complicated obesity. This systematic review of enteric hyperoxaluria was completed as part of a Kidney Health Initiative–sponsored project to describe enteric hyperoxaluria pathophysiology, causes, outcomes, and therapies. Current therapeutic options are limited to correcting the underlying gastrointestinal disorder, intensive dietary modifications, and use of calcium salts to bind oxalate in the gut. Evidence for the effect of these treatments on clinically significant outcomes, including kidney stone events or CKD, is currently lacking. Thus, further research is needed to better define the precise factors that influence risk of adverse outcomes, the long-term efficacy of available treatment strategies, and to develop new therapeutic approaches.Witting, CelesteLangman, Craig B.Assimos, DeanBaum, Michelle A.Kausz, AnnamariaMilliner, DawnTasian, GregWorcester, ElaineAllain, MeaghanWest, MelissaKnauf, FelixLieske, John C.2020-09-08T08:21:41-07:00doi:10.2215/CJN.08000520hwp:resource-id:clinjasn;16/3/487American Society of NephrologyCopyright © 2021 by the American Society of NephrologyClinical Journal of the American Society of Nephrologychronic kidney disease, hyperoxaluria, fat malabsorption, nephrolithiasisReviewReviewreview-article20212021-03-08March 08, 202110.2215/CJN.080005201555-90411555-905X2020-09-08T08:21:41-07:002021-03-08Clinical Journal of the American Society of NephrologyReview163487495http://jasn.asnjournals.org/lookup/doi/10.1681/ASN.2020101466?cct=237510.1681/ASN.2020101466Wed, 30 Dec 2020 07:39:40 GMT-08:00Ensuring the Equitable Advancement of American Kidney Health—the Need to Account for Socioeconomic Disparities in the ESRD Treatment Choices ModelReddy, Yuvaram N.V.Tummalapalli, Sri LekhaMendu, Mallika L.2020-12-30T07:39:40-08:00doi:10.1681/ASN.2020101466hwp:resource-id:jnephrol;32/2/265American Society of NephrologyCopyright © 2021 by the American Society of NephrologyJournal of the American Society of NephrologyAdvancing American Kidney Health initiative, social determinants of health, health policy, home dialysis, ESRD Treatment Choices modelUp Front MattersPerspectivesUp Front MattersPerspectivesresearch-article20212021-02-01February 202110.1681/ASN.20201014661046-66731533-34502020-12-30T07:39:40-08:002021-02Journal of the American Society of NephrologyUp Front Matters322265267http://cjasn.asnjournals.org/lookup/doi/10.2215/CJN.03960320?cct=237510.2215/CJN.03960320Fri, 24 Jul 2020 07:39:49 GMT-07:00The Role of Incremental Peritoneal Dialysis in the Era of the Advancing American Kidney Health InitiativeReddy, Yuvaram N.V.Mendu, Mallika L.2020-07-24T07:39:49-07:00doi:10.2215/CJN.03960320hwp:resource-id:clinjasn;15/12/1835American Society of NephrologyCopyright © 2020 by the American Society of NephrologyClinical Journal of the American Society of Nephrologydialysis, economic impact, end stage kidney disease, end-stage renal disease, peritoneal dialysis, peritoneal membrane, kidneyPerspectivesPerspectivesresearch-article20202020-12-07December 07, 202010.2215/CJN.039603201555-90411555-905X2020-07-24T07:39:49-07:002020-12-07Clinical Journal of the American Society of NephrologyPerspectives151218351837http://kidney360.asnjournals.org/lookup/doi/10.34067/KID.0002392020?cct=2375In-center hemodialysis (HD) remains the predominant dialysis therapy in patients with ESKD. Many patients with ESKD present in late stage, requiring urgent dialysis initiation, and the majority start HD with central venous catheters (CVCs), which are associated with poor outcomes and high cost of care. Peritoneal dialysis (PD) catheters can be safely placed in such patients with late-presenting ESKD, obviating the need for CVCs. PD can begin almost immediately in the recumbent position, using low fill volumes. Such PD initiations, commencing within 2 weeks of the catheter placement, are termed urgent-start PD (USPD). Most patients with an intact peritoneal cavity and stable home situation are eligible for USPD. Although there is a small risk of PD catheter–related mechanical complications, most can be managed conservatively. Moreover, overall outcomes of USPD are comparable to those with planned PD initiations, in contrast to the high rate of catheter-related infections and bacteremia associated with urgent-start HD. The ongoing coronavirus disease 2019 pandemic has further exposed the vulnerability of patients with ESKD getting in-center HD. PD can mitigate the risk of infection by reducing environmental exposure to the virus. Thus, USPD is a safe and cost-effective option for unplanned dialysis initiation in patients with late-presenting ESKD. To develop a successful USPD program, a strong infrastructure with clear pathways is essential. Coordination of care between nephrologists, surgeons or interventionalists, and hospital and PD center staff is imperative so that patient education, home visits, PD catheter placements, and urgent PD initiations are accomplished expeditiously. Implementation of urgent-start PD will help to increase PD use, reduce cost, and improve patient outcomes, and will be a step forward in fostering the goal set by the Advancing American Kidney Health initiative.10.34067/KID.0002392020Tue, 11 Aug 2020 06:18:52 GMT-07:00How To Build a Successful Urgent-Start Peritoneal Dialysis ProgramIn-center hemodialysis (HD) remains the predominant dialysis therapy in patients with ESKD. Many patients with ESKD present in late stage, requiring urgent dialysis initiation, and the majority start HD with central venous catheters (CVCs), which are associated with poor outcomes and high cost of care. Peritoneal dialysis (PD) catheters can be safely placed in such patients with late-presenting ESKD, obviating the need for CVCs. PD can begin almost immediately in the recumbent position, using low fill volumes. Such PD initiations, commencing within 2 weeks of the catheter placement, are termed urgent-start PD (USPD). Most patients with an intact peritoneal cavity and stable home situation are eligible for USPD. Although there is a small risk of PD catheter–related mechanical complications, most can be managed conservatively. Moreover, overall outcomes of USPD are comparable to those with planned PD initiations, in contrast to the high rate of catheter-related infections and bacteremia associated with urgent-start HD. The ongoing coronavirus disease 2019 pandemic has further exposed the vulnerability of patients with ESKD getting in-center HD. PD can mitigate the risk of infection by reducing environmental exposure to the virus. Thus, USPD is a safe and cost-effective option for unplanned dialysis initiation in patients with late-presenting ESKD. To develop a successful USPD program, a strong infrastructure with clear pathways is essential. Coordination of care between nephrologists, surgeons or interventionalists, and hospital and PD center staff is imperative so that patient education, home visits, PD catheter placements, and urgent PD initiations are accomplished expeditiously. Implementation of urgent-start PD will help to increase PD use, reduce cost, and improve patient outcomes, and will be a step forward in fostering the goal set by the Advancing American Kidney Health initiative.Rajora, NilumShastri, ShaniPirwani, GulzarSaxena, Ramesh2020-08-11T06:18:52-07:00doi:10.34067/KID.0002392020hwp:resource-id:kidney360;1/10/1165American Society of NephrologyCopyright © 2020 by the American Society of NephrologyKidney360dialysis, end stage kidney disease, peritoneal dialysis, unplanned dialysis initiations, urgent-start peritoneal dialysisReview ArticlesReview Articlesreview-article20202020-10-2910.34067/KID.00023920202641-76502020-08-11T06:18:52-07:002020-10-29Kidney360Review Articles11011651177http://cjasn.asnjournals.org/lookup/doi/10.2215/CJN.00110120?cct=2375Individuals with dialysis-dependent kidney failure experience considerable disease- and treatment-related decline in functional status and overall well-being. Despite these experiences, there have been few substantive technological advances in KRT in decades. As such, new federal initiatives seek to accelerate innovation. Historically, integration of patient perspectives into KRT product development has been limited. However, the US Food and Drug Administration recognizes the importance of incorporating patient perspectives into the total product life cycle (i.e., from product conception to postmarket surveillance) and encourages the consideration of patient-reported outcomes in regulatory-focused clinical trials when appropriate. Recognizing the significance of identifying patient-reported outcome measures (PROMs) that capture contemporary patient priorities, the Kidney Health Initiative, a public–private partnership between the American Society of Nephrology and US Food and Drug Administration, convened a workgroup to (1) develop a conceptual framework for a health-related quality of life PROM; (2) identify and map existing PROMs to the conceptual framework, prioritizing them on the basis of their supporting evidence for use in the regulatory environment; and (3) describe next steps for identifying PROMs for use in regulatory clinical trials of transformative KRT devices. This paper summarizes the proposed health-related quality-of-life PROM conceptual framework, maps and prioritizes PROMs, and identifies gaps and future needs to advance the development of rigorous, meaningful PROMS for use in clinical trials of transformative KRT devices.10.2215/CJN.00110120Fri, 10 Apr 2020 09:20:11 GMT-07:00Toward Patient-Centered InnovationIndividuals with dialysis-dependent kidney failure experience considerable disease- and treatment-related decline in functional status and overall well-being. Despite these experiences, there have been few substantive technological advances in KRT in decades. As such, new federal initiatives seek to accelerate innovation. Historically, integration of patient perspectives into KRT product development has been limited. However, the US Food and Drug Administration recognizes the importance of incorporating patient perspectives into the total product life cycle (i.e., from product conception to postmarket surveillance) and encourages the consideration of patient-reported outcomes in regulatory-focused clinical trials when appropriate. Recognizing the significance of identifying patient-reported outcome measures (PROMs) that capture contemporary patient priorities, the Kidney Health Initiative, a public–private partnership between the American Society of Nephrology and US Food and Drug Administration, convened a workgroup to (1) develop a conceptual framework for a health-related quality of life PROM; (2) identify and map existing PROMs to the conceptual framework, prioritizing them on the basis of their supporting evidence for use in the regulatory environment; and (3) describe next steps for identifying PROMs for use in regulatory clinical trials of transformative KRT devices. This paper summarizes the proposed health-related quality-of-life PROM conceptual framework, maps and prioritizes PROMs, and identifies gaps and future needs to advance the development of rigorous, meaningful PROMS for use in clinical trials of transformative KRT devices.Flythe, Jennifer E.Hilliard, Tandrea S.Ikeler, KourtneyKeller, SanGipson, Debbie S.Grandinetti, Amanda C.Nordyke, Robert J.Perrone, Ronald D.Roy-Chaudhury, PrabirUnruh, MarkWest, MelissaBocell, FraserHurst, Frank P.2020-04-10T09:20:11-07:00doi:10.2215/CJN.00110120hwp:resource-id:clinjasn;15/10/1522American Society of NephrologyCopyright © 2020 by the American Society of NephrologyClinical Journal of the American Society of Nephrologypatient-reported outcomes, medical devices, innovation, dialysis, hemodialysis, end-stage renal disease, patient priorities, clinical trial, renal dialysis, quality of life, Public-Private Sector Partnerships, United States Food and Drug Administration, Patient Reported Outcome Measures, Renal Insufficiency, Renal Replacement Therapy, kidney, Patient-Centered CareFeaturesFeaturesresearch-article20202020-10-07October 07, 202010.2215/CJN.001101201555-90411555-905X2020-04-10T09:20:11-07:002020-10-07Clinical Journal of the American Society of NephrologyFeatures151015221530http://cjasn.asnjournals.org/lookup/doi/10.2215/CJN.13821119?cct=2375Patients with primary hyperoxaluria experience kidney stones from a young age and can develop progressive oxalate nephropathy. Progression to kidney failure often develops over a number of years, and is associated with systemic oxalosis, intensive dialysis, and often combined kidney and liver transplantation. There are no therapies approved by the Food and Drug Association. Thus, the Kidney Health Initiative, in partnership with the Oxalosis and Hyperoxaluria Foundation, initiated a project to identify end points for clinical trials. A workgroup of physicians, scientists, patients with primary hyperoxaluria, industry, and United States regulators critically examined the published literature for clinical outcomes and potential surrogate end points that could be used to evaluate new treatments. Kidney stones, change in eGFR, urine oxalate, and plasma oxalate were the strongest candidate end points. Kidney stones affect how patients with primary hyperoxaluria feel and function, but standards for measurement and monitoring are lacking. Primary hyperoxaluria registry data suggest that eGFR decline in most patients is gradual, but can be unpredictable. Epidemiologic data show a strong relationship between urine oxalate and long-term kidney function loss. Urine oxalate is reasonably likely to predict clinical benefit, due to its causal role in stone formation and kidney damage in CKD stages 1–3a, and plasma oxalate is likely associated with risk of systemic oxalosis in CKD 3b–5. Change in slope of eGFR could be considered the equivalent of a clinically meaningful end point in support of traditional approval. A substantial change in urine oxalate as a surrogate end point could support traditional approval in patients with primary hyperoxaluria type 1 and CKD stages 1–3a. A substantial change in markedly elevated plasma oxalate could support accelerated approval in patients with primary hyperoxaluria and CKD stages 3b–5. Primary hyperoxaluria type 1 accounts for the preponderance of available data, thus heavily influences the conclusions. Addressing gaps in data will further facilitate testing of promising new treatments, accelerating improved outcomes for patients with primary hyperoxaluria.10.2215/CJN.13821119Thu, 12 Mar 2020 07:57:36 GMT-07:00End Points for Clinical Trials in Primary HyperoxaluriaPatients with primary hyperoxaluria experience kidney stones from a young age and can develop progressive oxalate nephropathy. Progression to kidney failure often develops over a number of years, and is associated with systemic oxalosis, intensive dialysis, and often combined kidney and liver transplantation. There are no therapies approved by the Food and Drug Association. Thus, the Kidney Health Initiative, in partnership with the Oxalosis and Hyperoxaluria Foundation, initiated a project to identify end points for clinical trials. A workgroup of physicians, scientists, patients with primary hyperoxaluria, industry, and United States regulators critically examined the published literature for clinical outcomes and potential surrogate end points that could be used to evaluate new treatments. Kidney stones, change in eGFR, urine oxalate, and plasma oxalate were the strongest candidate end points. Kidney stones affect how patients with primary hyperoxaluria feel and function, but standards for measurement and monitoring are lacking. Primary hyperoxaluria registry data suggest that eGFR decline in most patients is gradual, but can be unpredictable. Epidemiologic data show a strong relationship between urine oxalate and long-term kidney function loss. Urine oxalate is reasonably likely to predict clinical benefit, due to its causal role in stone formation and kidney damage in CKD stages 1–3a, and plasma oxalate is likely associated with risk of systemic oxalosis in CKD 3b–5. Change in slope of eGFR could be considered the equivalent of a clinically meaningful end point in support of traditional approval. A substantial change in urine oxalate as a surrogate end point could support traditional approval in patients with primary hyperoxaluria type 1 and CKD stages 1–3a. A substantial change in markedly elevated plasma oxalate could support accelerated approval in patients with primary hyperoxaluria and CKD stages 3b–5. Primary hyperoxaluria type 1 accounts for the preponderance of available data, thus heavily influences the conclusions. Addressing gaps in data will further facilitate testing of promising new treatments, accelerating improved outcomes for patients with primary hyperoxaluria.Milliner, Dawn S.McGregor, Tracy L.Thompson, AlizaDehmel, BastianKnight, JohnRosskamp, RalfBlank, MelanieYang, SixunFargue, SoniaRumsby, GillGroothoff, JaapAllain, MeaghanWest, MelissaHollander, KimLowther, W. ToddLieske, John C.2020-03-12T07:57:36-07:00doi:10.2215/CJN.13821119hwp:resource-id:clinjasn;15/7/1056American Society of NephrologyCopyright © 2020 by the American Society of NephrologyClinical Journal of the American Society of Nephrologyoxalate, kidney stones, clinical trial end points, rare kidney disease, primary hyperoxaluria type 1, hyperoxaluria, primary, liver transplantation, renal dialysis, hyperoxaluria, kidney calculi, kidney, renal insufficiency, registries, biomarkers, renal insufficiency, chronicFeatureFeatureresearch-article20202020-07-01July 01, 202010.2215/CJN.138211191555-90411555-905X2020-03-12T07:57:36-07:002020-07-01Clinical Journal of the American Society of NephrologyFeature15710561065http://cjasn.asnjournals.org/lookup/doi/10.2215/CJN.13831119?cct=237510.2215/CJN.13831119Thu, 12 Mar 2020 07:57:36 GMT-07:00Primary HyperoxaluriaLawrence, Jennifer E.Wattenberg, Debra J.2020-03-12T07:57:36-07:00doi:10.2215/CJN.13831119hwp:resource-id:clinjasn;15/7/909American Society of NephrologyCopyright © 2020 by the American Society of NephrologyClinical Journal of the American Society of Nephrologyprimary hyperoxaluria, patient perspective, hyperoxaluria, kidney stones, genetic disease, child, adult, humans, preschool child, adolescent, primary hyperoxaluria type 1, caregivers, gastrostomy, water, renal dialysis, oxalates, kidney calculi, kidney, parents, surveys and questionnaires, internet, type 2 diabetes mellitusPatient VoicePatient Voiceeditorial20202020-07-01July 01, 202010.2215/CJN.138311191555-90411555-905X2020-03-12T07:57:36-07:002020-07-01Clinical Journal of the American Society of NephrologyPatient Voice157909911http://cjasn.asnjournals.org/lookup/doi/10.2215/CJN.15031219?cct=237510.2215/CJN.15031219Tue, 14 Apr 2020 10:16:18 GMT-07:00Kidney Health Initiative Roadmap for Kidney Replacement TherapyGee, Patrick O.2020-04-14T10:16:18-07:00doi:10.2215/CJN.15031219hwp:resource-id:clinjasn;15/5/585American Society of NephrologyCopyright © 2020 by the American Society of NephrologyClinical Journal of the American Society of NephrologyRenal Replacement Therapy, Acute Kidney InjuryPatient VoicePatient Voiceresearch-article20202020-05-07May 07, 202010.2215/CJN.150312191555-90411555-905X2020-04-14T10:16:18-07:002020-05-07Clinical Journal of the American Society of NephrologyPatient Voice155585586http://cjasn.asnjournals.org/lookup/doi/10.2215/CJN.11060919?cct=237510.2215/CJN.11060919Fri, 06 Dec 2019 07:58:57 GMT-08:00How the Kidney Health Initiative Catalyzes Innovation in a Dynamic EnvironmentHarris, Raymond C.Cahill, Zachary2019-12-06T07:58:57-08:00doi:10.2215/CJN.11060919hwp:resource-id:clinjasn;15/3/421American Society of NephrologyCopyright © 2020 by the American Society of NephrologyClinical Journal of the American Society of NephrologyHumans, United States, nephrology, public-private sector partnerships, United States Food and Drug Administration, public health, goals, kidney diseases, kidney, United States Dept. of Health and Human Services, government, attentionPerspectivesPerspectivesresearch-article20202020-03-06March 06, 202010.2215/CJN.110609191555-90411555-905X2019-12-06T07:58:57-08:002020-03-06Clinical Journal of the American Society of NephrologyPerspectives153421422http://cjasn.asnjournals.org/lookup/doi/10.2215/CJN.02570319?cct=2375The number of patients dialyzed for ESKD exceeds 500,000 in the United States and more than 2.6 million people worldwide, with the expectation that the worldwide number will double by 2030. The human cost of health and societal financial cost of ESKD is substantial. Dialytic therapy is associated with an unacceptably high morbidity and mortality rate and poor quality of life. Although innovation in many areas of science has been transformative, there has been little innovation in dialysis or alternatives for kidney replacement therapy (KRT) since its introduction approximately 70 years ago. Advances in kidney biology, stem cells and kidney cell differentiation protocols, biomaterials, sensors, nano/microtechnology, sorbents and engineering, and interdisciplinary approaches and collaborations can lead to disruptive innovation. The Kidney Health Initiative, a public–private partnership between the American Society of Nephrology and the US Food and Drug Administration, has convened a multidisciplinary group to create a technology roadmap for innovative approaches to KRT to address patients’ needs. The Roadmap is a living document. It identifies the design criteria that must be considered to replace the myriad functions of the kidney, as well as scientific, technical, regulatory, and payor milestones required to commercialize and provide patient access to KRT alternatives. Various embodiments of potential solutions are discussed, but the Roadmap is agnostic to any particular solution set. System enablers are identified, including vascular access, biomaterial development, biologic and immunologic modulation, function, and safety monitoring. Important Roadmap supporting activities include regulatory alignment and innovative financial incentives and payment pathways. The Roadmap provides estimated timelines for replacement of specific kidney functions so that approaches can be conceptualized in ways that are actionable and attract talented innovators from multiple disciplines. The Roadmap has been used to guide the selection of KidneyX prizes for innovation in KRT.10.2215/CJN.02570319Fri, 27 Sep 2019 05:40:12 GMT-07:00A Technology Roadmap for Innovative Approaches to Kidney Replacement TherapiesThe number of patients dialyzed for ESKD exceeds 500,000 in the United States and more than 2.6 million people worldwide, with the expectation that the worldwide number will double by 2030. The human cost of health and societal financial cost of ESKD is substantial. Dialytic therapy is associated with an unacceptably high morbidity and mortality rate and poor quality of life. Although innovation in many areas of science has been transformative, there has been little innovation in dialysis or alternatives for kidney replacement therapy (KRT) since its introduction approximately 70 years ago. Advances in kidney biology, stem cells and kidney cell differentiation protocols, biomaterials, sensors, nano/microtechnology, sorbents and engineering, and interdisciplinary approaches and collaborations can lead to disruptive innovation. The Kidney Health Initiative, a public–private partnership between the American Society of Nephrology and the US Food and Drug Administration, has convened a multidisciplinary group to create a technology roadmap for innovative approaches to KRT to address patients’ needs. The Roadmap is a living document. It identifies the design criteria that must be considered to replace the myriad functions of the kidney, as well as scientific, technical, regulatory, and payor milestones required to commercialize and provide patient access to KRT alternatives. Various embodiments of potential solutions are discussed, but the Roadmap is agnostic to any particular solution set. System enablers are identified, including vascular access, biomaterial development, biologic and immunologic modulation, function, and safety monitoring. Important Roadmap supporting activities include regulatory alignment and innovative financial incentives and payment pathways. The Roadmap provides estimated timelines for replacement of specific kidney functions so that approaches can be conceptualized in ways that are actionable and attract talented innovators from multiple disciplines. The Roadmap has been used to guide the selection of KidneyX prizes for innovation in KRT.Bonventre, Joseph V.Hurst, Frank P.West, MelissaWu, IwenRoy-Chaudhury, PrabirSheldon, Murray2019-09-27T05:40:12-07:00doi:10.2215/CJN.02570319hwp:resource-id:clinjasn;14/10/1539American Society of NephrologyCopyright © 2019 by the American Society of NephrologyClinical Journal of the American Society of Nephrologydialysis, kidney bioengineering, xenotransplantation, kidney chimeras, proximal tubule, toxicity, secretion, RRT access, blood filtration, electrolyte homeostasis, kidney organoid, nephrology, renal dialysis, kidney dialysis, biocompatible materials, microtechnology, United States Food and Drug Administration, motivation, public-private sector partnerships, quality of life, chronic kidney failure, renal replacement therapy, kidney, urinary tract physiological phenomena; stem cellsFeatureFeatureresearch-article20192019-10-07October 07, 201910.2215/CJN.025703191555-90411555-905X2019-09-27T05:40:12-07:002019-10-07Clinical Journal of the American Society of NephrologyFeature141015391547http://cjasn.asnjournals.org/lookup/doi/10.2215/CJN.07670618?cct=2375Individuals receiving in-center maintenance hemodialysis bear a high burden of both physical and mood symptoms. More than half of patients on hemodialysis report sleep disturbance, muscle cramps, and fatigue. Patients describe symptoms as having a deleterious effect on their quality of life, suggesting that symptom alleviation may meaningfully improve patient-reported outcomes. Moreover, patients on hemodialysis have identified symptom management as a key area for research and innovation, prioritizing symptom alleviation over other health outcomes such as mortality and biochemical indices. Despite the importance of symptoms to patients, there has been little research explicitly geared toward improving patient symptoms, and therefore minimal innovation in symptom management. In general, the physiologic underpinnings of symptoms are poorly understood, hampering the development of targeted therapies. In fact, there have been few drugs or devices approved by the US Food and Drug Administration for the indication of improving any patient-reported outcomes for patients on hemodialysis. Recognizing this gap in innovation, the Kidney Health Initiative, a public–private partnership between the American Society of Nephrology and US Food and Drug Administration, convened a workgroup to first prioritize symptoms for the development of therapeutic interventions, and then identify near-term actionable research goals for the prioritized physical symptoms of insomnia, muscle cramps, and fatigue. This paper summarizes the pathophysiology of the three prioritized symptoms, identifies key knowledge gaps, acknowledges factors that challenge development of new therapies, and offers the nephrology community actionable research goals for insomnia, muscle cramps, and fatigue.10.2215/CJN.07670618Mon, 05 Nov 2018 09:59:00 GMT-08:00Fostering Innovation in Symptom Management among Hemodialysis PatientsIndividuals receiving in-center maintenance hemodialysis bear a high burden of both physical and mood symptoms. More than half of patients on hemodialysis report sleep disturbance, muscle cramps, and fatigue. Patients describe symptoms as having a deleterious effect on their quality of life, suggesting that symptom alleviation may meaningfully improve patient-reported outcomes. Moreover, patients on hemodialysis have identified symptom management as a key area for research and innovation, prioritizing symptom alleviation over other health outcomes such as mortality and biochemical indices. Despite the importance of symptoms to patients, there has been little research explicitly geared toward improving patient symptoms, and therefore minimal innovation in symptom management. In general, the physiologic underpinnings of symptoms are poorly understood, hampering the development of targeted therapies. In fact, there have been few drugs or devices approved by the US Food and Drug Administration for the indication of improving any patient-reported outcomes for patients on hemodialysis. Recognizing this gap in innovation, the Kidney Health Initiative, a public–private partnership between the American Society of Nephrology and US Food and Drug Administration, convened a workgroup to first prioritize symptoms for the development of therapeutic interventions, and then identify near-term actionable research goals for the prioritized physical symptoms of insomnia, muscle cramps, and fatigue. This paper summarizes the pathophysiology of the three prioritized symptoms, identifies key knowledge gaps, acknowledges factors that challenge development of new therapies, and offers the nephrology community actionable research goals for insomnia, muscle cramps, and fatigue.Flythe, Jennifer E.Hilliard, TandreaLumby, ElenaCastillo, GracielaOrazi, JazmineAbdel-Rahman, Emaad M.Pai, Amy BartonRivara, Matthew BertrandSt. Peter, Wendy L.Weisbord, Steven DarrowWilkie, Caroline M.Mehrotra, Rajnish,2018-11-05T09:59:00-08:00doi:10.2215/CJN.07670618hwp:resource-id:clinjasn;14/1/150American Society of NephrologyCopyright © 2019 by the American Society of NephrologyClinical Journal of the American Society of Nephrologychronic dialysis, dialysis, end stage kidney disease, ESRD, hemodialysis, ESKD, kidney diseaseFeatureFeatureresearch-article20192019-01-07January 07, 201910.2215/CJN.076706181555-90411555-905X2018-11-05T09:59:00-08:002019-01-07Clinical Journal of the American Society of NephrologyFeature141150160http://cjasn.asnjournals.org/lookup/doi/10.2215/CJN.08600718?cct=2375IgA nephropathy (IgAN) is an important cause of ESKD for which there are no approved therapies. A challenge for evaluating treatments for IgAN is the usual long time course for progression to ESKD. The aim of this Kidney Health Initiative project was to identify surrogate end points that could serve as reliable predictors of a treatment’s effect on long-term kidney outcomes in IgAN and be used as a basis for approval. Proteinuria was identified as the most widely recognized and well studied risk factor for progression to ESKD in IgAN. The workgroup performed a critical review of the data on proteinuria reduction as a surrogate end point for a treatment’s effect on progression to ESKD in IgAN. Epidemiologic data indicate a strong and consistent relationship between the level and duration of proteinuria and loss of kidney function. Trial-level analyses of data from 13 controlled trials also show an association between treatment effects on percent reduction of proteinuria and treatment effects on a composite of time to doubling of serum creatinine, ESKD, or death. We conclude that data support the use of proteinuria reduction as a reasonably likely surrogate end point for a treatment’s effect on progression to ESKD in IgAN. In the United States, reasonably likely surrogate end points can be used as a basis for accelerated approval of therapies intended to treat serious or life-threatening conditions, such as IgAN. The clinical benefit of products approved under this program would need to be verified in a postmarketing confirmatory trial.10.2215/CJN.08600718Fri, 11 Jan 2019 09:16:22 GMT-08:00Proteinuria Reduction as a Surrogate End Point in Trials of IgA NephropathyIgA nephropathy (IgAN) is an important cause of ESKD for which there are no approved therapies. A challenge for evaluating treatments for IgAN is the usual long time course for progression to ESKD. The aim of this Kidney Health Initiative project was to identify surrogate end points that could serve as reliable predictors of a treatment’s effect on long-term kidney outcomes in IgAN and be used as a basis for approval. Proteinuria was identified as the most widely recognized and well studied risk factor for progression to ESKD in IgAN. The workgroup performed a critical review of the data on proteinuria reduction as a surrogate end point for a treatment’s effect on progression to ESKD in IgAN. Epidemiologic data indicate a strong and consistent relationship between the level and duration of proteinuria and loss of kidney function. Trial-level analyses of data from 13 controlled trials also show an association between treatment effects on percent reduction of proteinuria and treatment effects on a composite of time to doubling of serum creatinine, ESKD, or death. We conclude that data support the use of proteinuria reduction as a reasonably likely surrogate end point for a treatment’s effect on progression to ESKD in IgAN. In the United States, reasonably likely surrogate end points can be used as a basis for accelerated approval of therapies intended to treat serious or life-threatening conditions, such as IgAN. The clinical benefit of products approved under this program would need to be verified in a postmarketing confirmatory trial.Thompson, AlizaCarroll, KevinA. Inker, LesleyFloege, JürgenPerkovic, VladoBoyer-Suavet, SoniaW. Major, RupertI. Schimpf, JudithBarratt, JonathanCattran, Daniel C.S. Gillespie, BarbaraKausz, AnnamariaW. Mercer, AlexReich, Heather N.H. Rovin, BradWest, MelissaNachman, Patrick H.2019-01-11T09:16:22-08:00doi:10.2215/CJN.08600718hwp:resource-id:clinjasn;14/3/469American Society of NephrologyCopyright © 2019 by the American Society of NephrologyClinical Journal of the American Society of NephrologyIgA nephropathy, surrogate endpoint, clinical trials, Glomerulonephritis, IGA, creatinine, risk factors, proteinuria, kidney, Kidney Failure, ChronicFeatureFeatureresearch-article20192019-03-07March 7, 201910.2215/CJN.086007181555-90411555-905X2019-01-11T09:16:22-08:002019-03-07Clinical Journal of the American Society of NephrologyFeature143469481http://cjasn.asnjournals.org/lookup/doi/10.2215/CJN.12641117?cct=2375Online hemodiafiltration provides greater removal of higher molecular weight uremic retention solutes than conventional high-flux hemodialysis. However, online hemodiafiltration is used sparsely in the United States in part because of a paucity of delivery systems cleared for clinical use by the US Food and Drug Administration. Although a pathway for regulatory approval exists in the United States, concerns remain, particularly regarding online production of the large volumes of sterile, nonpyrogenic substitution fluid infused directly into the bloodstream to maintain fluid balance. Clearly defined testing protocols, acceptable to Food and Drug Administration, will be useful to show that an online hemodiafiltration system is capable of routinely achieving a sterility assurance level of 10−6 and nonpyrogenic levels of endotoxin. Large-scale clinical experience has shown that systems providing this level of performance when combined with certain design features, such as redundancy, and an appropriate quality management process can routinely and safely produce substitution fluid for online hemodiafiltration.10.2215/CJN.12641117Tue, 06 Mar 2018 06:04:23 GMT-08:00Regulatory Considerations for Hemodiafiltration in the United StatesOnline hemodiafiltration provides greater removal of higher molecular weight uremic retention solutes than conventional high-flux hemodialysis. However, online hemodiafiltration is used sparsely in the United States in part because of a paucity of delivery systems cleared for clinical use by the US Food and Drug Administration. Although a pathway for regulatory approval exists in the United States, concerns remain, particularly regarding online production of the large volumes of sterile, nonpyrogenic substitution fluid infused directly into the bloodstream to maintain fluid balance. Clearly defined testing protocols, acceptable to Food and Drug Administration, will be useful to show that an online hemodiafiltration system is capable of routinely achieving a sterility assurance level of 10−6 and nonpyrogenic levels of endotoxin. Large-scale clinical experience has shown that systems providing this level of performance when combined with certain design features, such as redundancy, and an appropriate quality management process can routinely and safely produce substitution fluid for online hemodiafiltration.Ward, Richard A.Vienken, JörgSilverstein, Douglas M.Ash, StephenCanaud, Bernard2018-03-06T06:04:23-08:00doi:10.2215/CJN.12641117hwp:resource-id:clinjasn;13/9/1444American Society of NephrologyCopyright © 2018 by the American Society of NephrologyClinical Journal of the American Society of Nephrologyhemodiafiltration, regulatory approval, United States, United States Food and Drug Administration, Molecular Weight, renal dialysis, Maintenance, Online Systems, water-electrolyte balance, Endotoxins, InfertilityFeatureFeatureresearch-article20182018-09-07September 07, 201810.2215/CJN.126411171555-90411555-905X2018-03-06T06:04:23-08:002018-09-07Clinical Journal of the American Society of NephrologyFeature13914441449http://cjasn.asnjournals.org/lookup/doi/10.2215/CJN.12631117?cct=2375Hemodiafiltration combines diffusive and convective solute removal in a single therapy by ultrafiltering 20% or more of the blood volume processed using a high-flux hemodialyzer and maintaining fluid balance by infusing sterile nonpyrogenic replacement fluid directly into the patient’s blood. In online hemodiafiltration, the large volumes of replacement fluid required are obtained by online filtration of standard dialysate through a series of bacteria- and endotoxin-retaining filters. Currently available systems for online hemodiafiltration are on the basis of conventional dialysis machines with added features to safely prepare and infuse replacement fluid and closely control fluid balance. Hemodiafiltration provides greater removal of higher molecular weight uremic retention solutes than conventional high-flux hemodialysis, and recently completed randomized, controlled clinical trials suggest better patient survival with online hemodiafiltration compared with standard high-flux hemodialysis when a high convection volume is delivered. Hemodiafiltration is also associated with improvements in other clinical outcomes, such as a reduction in intradialytic hypotension, and it is now used routinely to treat >100,000 patients, mainly in Europe and Japan.10.2215/CJN.12631117Tue, 06 Mar 2018 06:04:22 GMT-08:00Hemodiafiltration to Address Unmet Medical Needs ESKD PatientsHemodiafiltration combines diffusive and convective solute removal in a single therapy by ultrafiltering 20% or more of the blood volume processed using a high-flux hemodialyzer and maintaining fluid balance by infusing sterile nonpyrogenic replacement fluid directly into the patient’s blood. In online hemodiafiltration, the large volumes of replacement fluid required are obtained by online filtration of standard dialysate through a series of bacteria- and endotoxin-retaining filters. Currently available systems for online hemodiafiltration are on the basis of conventional dialysis machines with added features to safely prepare and infuse replacement fluid and closely control fluid balance. Hemodiafiltration provides greater removal of higher molecular weight uremic retention solutes than conventional high-flux hemodialysis, and recently completed randomized, controlled clinical trials suggest better patient survival with online hemodiafiltration compared with standard high-flux hemodialysis when a high convection volume is delivered. Hemodiafiltration is also associated with improvements in other clinical outcomes, such as a reduction in intradialytic hypotension, and it is now used routinely to treat >100,000 patients, mainly in Europe and Japan.Canaud, BernardVienken, JörgAsh, StephenWard, Richard A.2018-03-06T06:04:22-08:00doi:10.2215/CJN.12631117hwp:resource-id:clinjasn;13/9/1435American Society of NephrologyCopyright © 2018 by the American Society of NephrologyClinical Journal of the American Society of NephrologyHemodiafiltration, Clinical outcomes, Technical requirements, Therapy prescription, Bacteria, Blood Volume, Convection, Dialysis Solutions, Endotoxins, Europe, Filtration, Humans, hypotension, Japan, Kidney Failure, Chronic, Kidneys, Artificial, Molecular Weight, renal dialysis, ultrafiltration, water-electrolyte balanceFeatureFeatureresearch-article20182018-09-07September 07, 201810.2215/CJN.126311171555-90411555-905X2018-03-06T06:04:22-08:002018-09-07Clinical Journal of the American Society of NephrologyFeature13914351443http://cjasn.asnjournals.org/lookup/doi/10.2215/CJN.10850917?cct=237510.2215/CJN.10850917Tue, 20 Mar 2018 06:45:41 GMT-07:00Symptom Prioritization among Adults Receiving In-Center HemodialysisFlythe, Jennifer E.Hilliard, TandreaCastillo, GracielaIkeler, KourtneyOrazi, JazmineAbdel-Rahman, EmaadPai, Amy BartonRivara, Matthew B.St. Peter, Wendy L.Weisbord, Steven D.Wilkie, CarolineMehrotra, Rajnish2018-03-20T06:45:41-07:00doi:10.2215/CJN.10850917hwp:resource-id:clinjasn;13/5/735American Society of NephrologyCopyright © 2018 by the American Society of NephrologyClinical Journal of the American Society of Nephrologychronic dialysis, dialysis, end-stage renal disease, ESRD, hemodialysis, Sleep Initiation and Maintenance Disorders, depression, Focus Groups, Frustration, quality of life, Anxiety, Emotions, Fatigue, Surveys and Questionnaires, Nausea, Vomiting, renal dialysis, PainOriginal ArticlesMaintenance DialysisOriginal ArticlesMaintenance Dialysisresearch-article20182018-05-07May 07, 201810.2215/CJN.108509171555-90411555-905X2018-03-20T06:45:41-07:002018-05-07Clinical Journal of the American Society of NephrologyOriginal Articles135735745http://cjasn.asnjournals.org/lookup/doi/10.2215/CJN.14251217?cct=2375Central venous catheters remain a vital option for access for patients receiving maintenance hemodialysis. There are many important and evolving clinical and regulatory considerations for all stakeholders for these devices. Innovation and transparent and comprehensive regulatory review of these devices is essential to stimulate innovation to help promote better outcomes for patients receiving maintenance hemodialysis. A workgroup that included representatives from academia, industry, and the US Food and Drug Administration was convened to identify the major design considerations and clinical and regulatory challenges of central venous catheters for hemodialysis. Our intent is to foster improved understanding of these devices and provide the foundation for strategies to foster innovation of these devices.10.2215/CJN.14251217Thu, 11 Oct 2018 05:36:10 GMT-07:00Clinical and Regulatory Considerations for Central Venous Catheters for HemodialysisCentral venous catheters remain a vital option for access for patients receiving maintenance hemodialysis. There are many important and evolving clinical and regulatory considerations for all stakeholders for these devices. Innovation and transparent and comprehensive regulatory review of these devices is essential to stimulate innovation to help promote better outcomes for patients receiving maintenance hemodialysis. A workgroup that included representatives from academia, industry, and the US Food and Drug Administration was convened to identify the major design considerations and clinical and regulatory challenges of central venous catheters for hemodialysis. Our intent is to foster improved understanding of these devices and provide the foundation for strategies to foster innovation of these devices.Silverstein, Douglas M.Trerotola, Scott O.Clark, TimothyJames, GarthNg, WingDwyer, AmyFlorescu, Marius C.Shingarev, RomanAsh, Stephen R.,2018-10-11T05:36:10-07:00doi:10.2215/CJN.14251217hwp:resource-id:clinjasn;13/12/1924American Society of NephrologyCopyright © 2018 by the American Society of NephrologyClinical Journal of the American Society of Nephrologychronic dialysis, dialysis access, end stage kidney disease, hemodialysis, hemodialysis accessFeaturesFeaturesresearch-article20182018-12-07December 07, 201810.2215/CJN.142512171555-90411555-905X2018-10-11T05:36:10-07:002018-12-07Clinical Journal of the American Society of NephrologyFeatures131219241932http://cjasn.asnjournals.org/lookup/doi/10.2215/CJN.13211117?cct=237510.2215/CJN.13211117Thu, 21 Dec 2017 10:04:43 GMT-08:00Trust Patient Insights at Both the Individual and National LevelConway, Paul T.2017-12-21T10:04:43-08:00doi:10.2215/CJN.13211117hwp:resource-id:clinjasn;13/1/1American Society of NephrologyCopyright © 2018 by the American Society of NephrologyClinical Journal of the American Society of Nephrologypatient engagement, Center for Dialysis Innovation, Kidney Health Initiative, Center for Clinical Trial Transformation, Kidney Precision Medicine Project, Kidney Innovation Accelerator, Health and Human Services, Patient Engagement Advisory Committee, Home peritoneal dialysis, kidney transplantation, hemodialysis, Patient Advocacy, Caregivers, nephrology, Leadership, Biological Phenomena, Physiological Phenomena, Trust, SocietiesPatient VoicePatient Voiceeditorial20182018-01-06January 06, 201810.2215/CJN.132111171555-90411555-905X2017-12-21T10:04:43-08:002018-01-06Clinical Journal of the American Society of NephrologyPatient Voice131111113631001092372108117http://cjasn.asnjournals.org/lookup/doi/10.2215/CJN.02900317?cct=2375In an effort to foster innovation and new product development, the American Society of Nephrology and the US Food and Drug Administration partnered to form the Kidney Health Initiative in 2012. Part of the Kidney Health Initiative’s mission is to foster development of therapies by creating a collaborative environment where the US Food and Drug Administration and the greater nephrology community can interact to optimize product evaluation. This particular Kidney Health Initiative project focused on products related to hemodialysis vascular access, with the goal of clarifying appropriate trial end points that could subsequently inform clinical, regulatory, and coverage decisions. Both the lack of common definitions and the lack of consensus on trial end points have been viewed as barriers to innovation in this area. Toward this end, the Kidney Health Initiative convened teams of expert stakeholders to address these issues for each major vascular access category (arteriovenous grafts, arteriovenous fistulas, and central venous catheters), and each team provided recommendations. This commentary provides an overview of the US Food and Drug Administration centers that regulate hemodialysis vascular access and certain laws and regulations that affect these products as well as our perspectives on some of the issues raised and end points proposed by the Kidney Health Initiative teams. The standardized definitions and clinical trial end points proposed by the teams represent an important step forward to improve innovation in this area.10.2215/CJN.02900317Mon, 24 Jul 2017 06:07:47 GMT-07:00FDA Regulatory Perspectives for Studies on Hemodialysis Vascular AccessIn an effort to foster innovation and new product development, the American Society of Nephrology and the US Food and Drug Administration partnered to form the Kidney Health Initiative in 2012. Part of the Kidney Health Initiative’s mission is to foster development of therapies by creating a collaborative environment where the US Food and Drug Administration and the greater nephrology community can interact to optimize product evaluation. This particular Kidney Health Initiative project focused on products related to hemodialysis vascular access, with the goal of clarifying appropriate trial end points that could subsequently inform clinical, regulatory, and coverage decisions. Both the lack of common definitions and the lack of consensus on trial end points have been viewed as barriers to innovation in this area. Toward this end, the Kidney Health Initiative convened teams of expert stakeholders to address these issues for each major vascular access category (arteriovenous grafts, arteriovenous fistulas, and central venous catheters), and each team provided recommendations. This commentary provides an overview of the US Food and Drug Administration centers that regulate hemodialysis vascular access and certain laws and regulations that affect these products as well as our perspectives on some of the issues raised and end points proposed by the Kidney Health Initiative teams. The standardized definitions and clinical trial end points proposed by the teams represent an important step forward to improve innovation in this area.Hurst, Frank P.Lee, Robert E.Thompson, Aliza M.Pullin, Brian D.Silverstein, Douglas M.2017-07-24T06:07:47-07:00doi:10.2215/CJN.02900317hwp:resource-id:clinjasn;13/3/513American Society of NephrologyCopyright © 2018 by the American Society of NephrologyClinical Journal of the American Society of Nephrologyend-stage renal disease, hemodialysis, hemodialysis access, vascular access, arteriovenous access, arteriovenous graft, arteriovenous fistula, Central Venous Catheters, Consensus, Goals, nephrology, renal dialysis, United StatesMoving Points in NephrologyMoving Points in Nephrologyresearch-article20182018-03-07March 07, 201810.2215/CJN.029003171555-90411555-905X2017-07-24T06:07:47-07:002018-03-07Clinical Journal of the American Society of NephrologyMoving Points in Nephrology133333513490495501518494500512http://cjasn.asnjournals.org/lookup/doi/10.2215/CJN.13321216?cct=237510.2215/CJN.13321216Tue, 27 Feb 2018 08:03:55 GMT-08:00Clinical Trial End Points for Hemodialysis Vascular AccessShenoy, SurendraAllon, MichaelBeathard, GeraldBrouwer-Maier, DeborahDember, Laura M.Glickman, MarkLee, CelesteLitchfield, TerryLok, CharmaineHuber, ThomasRoy-Chaudhury, PrabirWork, JackWest, MelissaWasse, Haimanot2018-02-27T08:03:55-08:00doi:10.2215/CJN.13321216hwp:resource-id:clinjasn;13/3/490American Society of NephrologyCopyright © 2018 by the American Society of NephrologyClinical Journal of the American Society of Nephrologyclinical trial, vascular, Humans, Consensus, Biological Products, renal dialysis, Polytetrafluoroethylene, arteriovenous fistulaMoving Points in NephrologyMoving Points in Nephrologyresearch-article20182018-03-07March 07, 201810.2215/CJN.133212161555-90411555-905X2018-02-27T08:03:55-08:002018-03-07Clinical Journal of the American Society of NephrologyMoving Points in Nephrology133333490495501513494500512518http://cjasn.asnjournals.org/lookup/doi/10.2215/CJN.12781216?cct=2375Telehealth and remote monitoring of a patient’s health status has become more commonplace in the last decade and has been applied to conditions such as heart failure, diabetes mellitus, hypertension, and chronic obstructive pulmonary disease. Conversely, uptake of these technologies to help engender and support home RRTs has lagged. Although studies have looked at the role of telehealth in RRT, they are small and single-centered, and both outcome and cost-effectiveness data are needed to inform future decision making. Furthermore, alignment of payer and government (federal and state) regulations with telehealth procedures is needed along with a better understanding of the viewpoints of the various stakeholders in this process (patients, caregivers, clinicians, payers, dialysis organizations, and government regulators). Despite these barriers, telehealth has great potential to increase the acceptance of home dialysis, and improve outcomes and patient satisfaction while potentially decreasing costs. The Kidney Health Initiative convened a multidisciplinary workgroup to examine the current state of telehealth use in home RRTs as well as outline potential benefits and drawbacks, impediments to implementation, and key unanswered questions.10.2215/CJN.12781216Fri, 14 Jul 2017 08:55:54 GMT-07:00Perspectives from the Kidney Health Initiative on Advancing Technologies to Facilitate Remote Monitoring of Patient Self-Care in RRTTelehealth and remote monitoring of a patient’s health status has become more commonplace in the last decade and has been applied to conditions such as heart failure, diabetes mellitus, hypertension, and chronic obstructive pulmonary disease. Conversely, uptake of these technologies to help engender and support home RRTs has lagged. Although studies have looked at the role of telehealth in RRT, they are small and single-centered, and both outcome and cost-effectiveness data are needed to inform future decision making. Furthermore, alignment of payer and government (federal and state) regulations with telehealth procedures is needed along with a better understanding of the viewpoints of the various stakeholders in this process (patients, caregivers, clinicians, payers, dialysis organizations, and government regulators). Despite these barriers, telehealth has great potential to increase the acceptance of home dialysis, and improve outcomes and patient satisfaction while potentially decreasing costs. The Kidney Health Initiative convened a multidisciplinary workgroup to examine the current state of telehealth use in home RRTs as well as outline potential benefits and drawbacks, impediments to implementation, and key unanswered questions.Rosner, Mitchell H.Lew, Susie Q.Conway, PaulEhrlich, JenniferJarrin, RobertPatel, Uptal D.Rheuban, KarenRobey, R. BrooksSikka, NealWallace, EricBrophy, PatrickSloand, James2017-07-14T08:55:54-07:00doi:10.2215/CJN.12781216hwp:resource-id:clinjasn;12/11/1900American Society of NephrologyCopyright © 2017 by the American Society of NephrologyClinical Journal of the American Society of NephrologyDialysis, monitoring, Caregivers, Cost-Benefit Analysis, diabetes mellitus, Government, Health Status, heart failure, Hemodialysis, Home, Humans, hypertension, Patient Satisfaction, Pulmonary Disease, Chronic Obstructive, renal dialysis, Self Care, TelemedicineReviewReviewreview-article20172017-11-07November 07, 201710.2215/CJN.127812161555-90411555-905X2017-07-14T08:55:54-07:002017-11-07Clinical Journal of the American Society of NephrologyReview121119001909http://cjasn.asnjournals.org/lookup/doi/10.2215/CJN.00540116?cct=2375Nephrology has conducted few high–quality clinical trials, and the trials that have been conducted have not resulted in the approval of new treatments for primary or inflammatory glomerular diseases. There are overarching process issues that affect the conduct of all clinical trials, but there are also some specialty–specific issues. Within nephrology, primary glomerular diseases are rare, making adequate recruitment for meaningful trials difficult. Nephrologists need better ways, beyond histopathology, to phenotype patients with glomerular diseases and stratify the risk for progression to ESRD. Rigorous trial design is needed for the testing of new therapies, where most patients with glomerular diseases are offered the opportunity to enroll in a clinical trial if standard therapies have failed or are lacking. Training programs to develop a core group of kidney specialists with expertise in the design and implementation of clinical trials are also needed. Registries of patients with glomerular disease and observational studies can aid in the ability to determine realistic estimates of disease prevalence and inform trial design through a better understanding of the natural history of disease. Some proposed changes to the Common Rule, the federal regulations governing the ethical conduct of research involving humans, and the emerging use of electronic health records may facilitate the efficiency of initiating multicenter clinical trials. Collaborations among academia, government scientific and regulatory agencies, industry, foundations, and patient advocacy groups can accelerate therapeutic development for these complex diseases.10.2215/CJN.00540116Mon, 26 Sep 2016 07:34:50 GMT-07:00Glomerular Diseases: Registries and Clinical TrialsNephrology has conducted few high–quality clinical trials, and the trials that have been conducted have not resulted in the approval of new treatments for primary or inflammatory glomerular diseases. There are overarching process issues that affect the conduct of all clinical trials, but there are also some specialty–specific issues. Within nephrology, primary glomerular diseases are rare, making adequate recruitment for meaningful trials difficult. Nephrologists need better ways, beyond histopathology, to phenotype patients with glomerular diseases and stratify the risk for progression to ESRD. Rigorous trial design is needed for the testing of new therapies, where most patients with glomerular diseases are offered the opportunity to enroll in a clinical trial if standard therapies have failed or are lacking. Training programs to develop a core group of kidney specialists with expertise in the design and implementation of clinical trials are also needed. Registries of patients with glomerular disease and observational studies can aid in the ability to determine realistic estimates of disease prevalence and inform trial design through a better understanding of the natural history of disease. Some proposed changes to the Common Rule, the federal regulations governing the ethical conduct of research involving humans, and the emerging use of electronic health records may facilitate the efficiency of initiating multicenter clinical trials. Collaborations among academia, government scientific and regulatory agencies, industry, foundations, and patient advocacy groups can accelerate therapeutic development for these complex diseases.Moxey-Mims, Marva M.Flessner, Michael F.Holzman, LawrenceKaskel, FrederickSedor, John R.Smoyer, William E.Thompson, Aliza M.Yao, Lynne2016-09-26T07:34:50-07:00doi:10.2215/CJN.00540116hwp:resource-id:clinjasn;11/12/2234American Society of NephrologyCopyright © 2016 by the American Society of NephrologyClinical Journal of the American Society of Nephrologyclinical trial, glomerular disease, registries, Cooperative Behavior, Electronic Health Records, Foundations, Government, Humans, kidney, Kidney Failure, Chronic, Kidney Glomerulus, nephrology, Patient Advocacy, Phenotype, Prevalence, Registries, Research, Science, SpecializationGlomerular Diseases: Update for the ClinicianGlomerular Diseases: Update for the Clinicianresearch-article20162016-12-07December 07, 201610.2215/CJN.005401161555-90411555-905X2016-09-26T07:34:50-07:002016-12-07Clinical Journal of the American Society of NephrologyGlomerular Diseases: Update for the Clinician111222342243http://cjasn.asnjournals.org/lookup/doi/10.2215/CJN.05630614?cct=2375The effect of AKI and modern continuous RRT (CRRT) methods on drug disposition (pharmacokinetics) and response has been poorly studied. Pharmaceutical manufacturers have little incentive to perform pharmacokinetic studies in patients undergoing CRRT because such studies are neither recommended in existing US Food and Drug Administration (FDA) guidance documents nor required for new drug approval. Action is urgently needed to address the knowledge deficit. The Kidney Health Initiative has assembled a work group composed of clinicians and scientists representing academia, the FDA, and the pharmaceutical and dialysis industries with expertise related to pharmacokinetics, AKI, and/or CRRT. The work group critically evaluated key considerations in the assessment of pharmacokinetics and drug dosing in CRRT, practical constraints related to conducting pharmacokinetic studies in critically ill patients, and the generalizability of observations made in the context of specific CRRT prescriptions and specific patient populations in order to identify efficient study designs capable of addressing the knowledge deficit without impeding drug development. Considerations for the standardized assessment of pharmacokinetics and development of corresponding drug dosing recommendations in critically ill patients with AKI receiving CRRT are proposed.10.2215/CJN.05630614Thu, 04 Sep 2014 07:00:46 GMT-07:00Pharmacokinetic Assessment in Patients Receiving Continuous RRT: Perspectives from the Kidney Health InitiativeThe effect of AKI and modern continuous RRT (CRRT) methods on drug disposition (pharmacokinetics) and response has been poorly studied. Pharmaceutical manufacturers have little incentive to perform pharmacokinetic studies in patients undergoing CRRT because such studies are neither recommended in existing US Food and Drug Administration (FDA) guidance documents nor required for new drug approval. Action is urgently needed to address the knowledge deficit. The Kidney Health Initiative has assembled a work group composed of clinicians and scientists representing academia, the FDA, and the pharmaceutical and dialysis industries with expertise related to pharmacokinetics, AKI, and/or CRRT. The work group critically evaluated key considerations in the assessment of pharmacokinetics and drug dosing in CRRT, practical constraints related to conducting pharmacokinetic studies in critically ill patients, and the generalizability of observations made in the context of specific CRRT prescriptions and specific patient populations in order to identify efficient study designs capable of addressing the knowledge deficit without impeding drug development. Considerations for the standardized assessment of pharmacokinetics and development of corresponding drug dosing recommendations in critically ill patients with AKI receiving CRRT are proposed.Nolin, Thomas D.Aronoff, George R.Fissell, William H.Jain, LokeshMadabushi, RajnikanthReynolds, KellieZhang, LeiHuang, Shiew MeiMehrotra, RajnishFlessner, Michael F.Leypoldt, John K.Witcher, Jennifer W.Zineh, IssamArchdeacon, PatrickRoy-Chaudhury, PrabirGoldstein, Stuart L.2014-09-04T07:00:46-07:00doi:10.2215/CJN.05630614hwp:resource-id:clinjasn;10/1/159American Society of NephrologyCopyright © 2015 by the American Society of NephrologyClinical Journal of the American Society of Nephrologypharmacokinetic, acute renal failure, dialysisSpecial FeatureSpecial Featureresearch-article20152015-01-07January 07, 201510.2215/CJN.056306141555-90411555-905X2014-09-04T07:00:46-07:002015-01-07Clinical Journal of the American Society of NephrologySpecial Feature101159164http://cjasn.asnjournals.org/lookup/doi/10.2215/CJN.01140113?cct=2375To respond to the serious and underrecognized epidemic of kidney disease in the United States, the US Food and Drug Administration and the American Society of Nephrology have founded the Kidney Health Initiative—a public–private partnership designed to create a collaborative environment in which the US Food and Drug Administration and the greater kidney community can interact to optimize the evaluation of drugs, devices, biologics, and food products. The Kidney Health Initiative will bring together all the necessary stakeholders, including patients, regulators, industry, health care providers, academics, and other governmental agencies, to improve patient safety and foster innovation. This initiative is intended to enable the kidney community as a whole to provide the right drug, device, or biologic for administration to the right patient at the right time by fostering partnerships that will facilitate development and delivery of those products and addressing challenges that currently impede these goals.10.2215/CJN.01140113Thu, 06 Jun 2013 08:38:30 GMT-07:00Fostering Innovation, Advancing Patient Safety: The Kidney Health InitiativeTo respond to the serious and underrecognized epidemic of kidney disease in the United States, the US Food and Drug Administration and the American Society of Nephrology have founded the Kidney Health Initiative—a public–private partnership designed to create a collaborative environment in which the US Food and Drug Administration and the greater kidney community can interact to optimize the evaluation of drugs, devices, biologics, and food products. The Kidney Health Initiative will bring together all the necessary stakeholders, including patients, regulators, industry, health care providers, academics, and other governmental agencies, to improve patient safety and foster innovation. This initiative is intended to enable the kidney community as a whole to provide the right drug, device, or biologic for administration to the right patient at the right time by fostering partnerships that will facilitate development and delivery of those products and addressing challenges that currently impede these goals.Archdeacon, PatrickShaffer, Rachel N.Winkelmayer, Wolfgang C.Falk, Ronald J.Roy-Chaudhury, Prabir2013-06-06T08:38:30-07:00doi:10.2215/CJN.01140113hwp:resource-id:clinjasn;8/9/1609American Society of NephrologyCopyright © 2013 by the American Society of NephrologyClinical Journal of the American Society of NephrologySpecial FeaturesSpecial Featuresresearch-article20132013-09-06September 06, 201310.2215/CJN.011401131555-90411555-905X2013-06-06T08:38:30-07:002013-09-06Clinical Journal of the American Society of NephrologySpecial Features8916091617