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KHI Publications

View and download publications produced by KHI workgroups.

Patient Preference Initiative

Publications from the "Building Capacity to Incorporate Patient Preferences into the Development of Innovative Alternatives to Renal Replacement Therapy (RRT)" project

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Xenotransplantation and the Role of the Patient VoiceMarch 7, 2024

  • Xenotransplantation and the Role of the Patient Voice
  • On behalf of the patient community, we are very grateful for the advances in xenotransplantation. The demand for kidney transplantation far exceeds the supply of available organs. Although increasing living donation and reducing kidney discard rates are important steps, neither will solve the problem. Advances in xenotransplantation represent a significant investment in innovation to solve a global problem. Historically, investment in kidney transplantation innovation pales in comparison with other specialty areas such as oncology.
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Risk Tolerance in the Setting of Wearable Dialysis Devices: A Patient Preference Study Using the Threshold Technique March 27, 2023

  • Risk Tolerance in the Setting of Wearable Dialysis Devices: A Patient Preference Study Using the Threshold Technique
  • Risk Tolerance in the Setting of Wearable Dialysis Devices: A Patient Preference Study Using the Threshold Technique , authored by Jennifer E. Flythe, MD, MPH on behalf of the project team shares the results of a patient preference survey for a future wearable dialysis device developed as part of a 30-month contract with the Center for Devices and Radiological Health (CDRH).
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Human Centered Design Toolkit for Treating Kidney Failure V2December 15, 2022

  • Human Centered Design Toolkit for Treating Kidney Failure V2
  • How might we identify innovations with the most impact on people's lives?
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Development of a Patient Preference Survey for Wearable Kidney Replacement Therapy DevicesMay 12, 2022

  • Development of a Patient Preference Survey for Wearable Kidney Replacement Therapy Devices
  • Recent innovations have the potential to disrupt the current paradigm for kidney failure treatment. The U.S. Food and Drug Administration is committed to incorporating valid scientific evidence about how patients weigh the benefits and risks of new devices into their decision-making, but to-date, premarket submission of patient preference information (PPI) has been limited for kidney devices. With input from stakeholders, we developed a survey intended to yield valid PPI, capturing how patients trade off the potential benefits and risks of wearable dialysis devices and in-center hemodialysis.
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Human Centered Design Toolkit for Treating Kidney Failure V1April 29, 2022

  • Human Centered Design Toolkit for Treating Kidney Failure V1
  • Version 1 of the Human Centered Design Toolkit for Kidney Failure
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Incorporating Patient Preferences via Bayesian Decision AnalysisApril 1, 2021

  • Incorporating Patient Preferences via Bayesian Decision Analysis
  • The regulatory process for market authorization of medical diagnostic and therapeutic products is fraught with ethical dilemmas that regulators outside the medical industry do not face. The consequences of approving an ineffective therapy with potentially dangerous side effects (a "Type I error" or false positive) must be weighed against not approving a safe and effective therapy (a "Type II error" or false negative) that could help ease the burden of disease for many patients. Regulators must strike the proper balance by considering multiple factors, including scientific merit, clinical evidence from randomized control trials, the burden of disease, the current standard of care and alternatives, and patient preferences. How these factors are—and should be—weighed is not always clear, which only encourages criticism by whichever stakeholder group disagrees with the decision.
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Integrating Patient Perspectives into Medical Device Regulatory Decision Making to Advance Innovation in Kidney DiseaseApril 1, 2021

  • Integrating Patient Perspectives into Medical Device Regulatory Decision Making to Advance Innovation in Kidney Disease
  • Understanding patient perspectives is critical to developing tailored care approaches that address patients' needs and wants, with the ultimate goal of improving patient satisfaction and quality of life. Methods to better measure patients' experiences living with their condition and its diagnosis, management, and treatment are also evolving. Tools are being developed that can robustly measure how patients feel and function, and quantitatively capture the relative value patients place on risks and benefits associated with treatments. With these tools in hand, the health care enterprise that includes medical product regulators, health care providers, and payers is uniquely poised to systematically incorporate the patient voice into its daily operations. This article highlights novel approaches the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA) has taken to establish systematic, sustained mechanisms for bringing the patient voice to bear in medical device evaluation.
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Legitimization and Incorporation of Patient PreferencesApril 1, 2021

  • Legitimization and Incorporation of Patient Preferences
  • We hope that at the point that readers see this CJASN article, they will have already read the three accompanying CJASN articles on patient preference information and patient-centered innovation in KRT (1⇓–3). These four articles represent a combined effort to chronicle the amazingly rapid application of the emerging science of patient insights, and the substantive effect it has already had as a legitimate body of evidence for policy and regulatory decision making within the realm of kidney disease and KRT. Each article provides information on the ascendancy of kidney patients within the scientific and policy processes.
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Overview of Various Components of the Science of Patient InputApril 1, 2021

  • Overview of Various Components of the Science of Patient Input
  • Advancing the Use of Patient-Reported, Real-World Evidence for Medical Device Evaluation of Innovative Products for the Treatment of Kidney Failure Using Strategically Coordinated Registry Networks
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Using Patient Preference Information to Inform Regulatory Decision MakingApril 1, 2021

  • Using Patient Preference Information to Inform Regulatory Decision Making
  • Medical devices play an essential role in the health care system, often facilitating patients' management of their own health. Such devices—items used for the "diagnosis…cure, mitigation, treatment, or prevention of disease that are not absorbed or metabolized by the body" (1)—range in type and function from supportive equipment (e.g., walkers and wheelchairs) to life-sustaining therapies (e.g., cardiac defibrillators and dialysis machines). In the United States, over 500,000 individuals with kidney failure rely on dialysis machines and supportive vascular access and monitoring devices to perform the critical kidney functions of waste and fluid removal. Although dialysis therapy undoubtedly sustains life, its side effects and burdensome nature leave many with constrained livelihoods and diminished quality of life.

Signature Initiatives

Publications that exemplify the strengths of KHI

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Roadmap for Advancing Awareness, Genetic Testing, and Clinical Testing of APOL1 Kidney DiseaseSeptember 24, 2024

  • Roadmap for Advancing Awareness, Genetic Testing, and Clinical Testing of APOL1 Kidney Disease
  • APOL1 kidney disease (APOL1 KD) is a driving force behind health disparities in chronic kidney disease (CKD) characterized by worse health outcomes for those of African ancestry. Despite this, there is little acknowledgement of APOL1 KD in kidney care, and only a few clinical studies currently seek to develop targeted treatments for this disease. Recognizing these gaps, the Kidney Health Initiative (KHI) initiated this effort to examine the APOL1 KD landscape and develop a roadmap to support the kidney health community in a coordinated effort to address APOL1 KD.
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FDA Resources for Developers of Innovative Approaches to Renal Replacement TherapyJuly 22, 2021

  • FDA Resources for Developers of Innovative Approaches to Renal Replacement Therapy
  • KHI has developed this FAQ guide to questions and challenges that developers of RRT solutions and/or those considering a clinical trial in this area encounter; developers should also consult with the review group regarding their specific situation.
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KHI RRT Product Terminology Fact SheetJuly 22, 2021

  • KHI RRT Product Terminology Fact Sheet
  • Defining Common Renal Replacement Therapy (RRT) Terminology
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A Technology Roadmap for Innovative Approaches to Kidney Replacement Therapies: A Catalyst for ChangeSeptember 27, 2019

  • A Technology Roadmap for Innovative Approaches to Kidney Replacement Therapies: A Catalyst for Change
  • The 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.
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Innovations in Fluid Management September 4, 2019

  • Innovations in Fluid Management
  • For patients with end stage renal disease (ESRD), renal replacement therapy (RRT) partially replaces the functions of a normal kidney, including maintaining volume balance. Proper volume balance is critical: either too much volume (hypervolemia) or too little volume (hypovolemia) can lead to complications
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RRT Technology Roadmap: Patient EditionSeptember 4, 2019

  • RRT Technology Roadmap: Patient Edition
  • The original RRT Technology Roadmap distilled into an approachable document for people with kidney disease interested in new technologies from the artificial kidney to next generation dialysis.
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Technology Roadmap for Innovative Alternatives to Renal Replacement TherapyOctober 25, 2018

  • Technology Roadmap for Innovative Alternatives to Renal Replacement Therapy
  • Recognizing that more rapid, innovative advancements in the treatment of kidney disease must be made, the Kidney Health Initiative (KHI) was created in September 2012. KHI is a public-private partnership between the American Society for Nephrology (ASN) and the U.S. Food and Drug Administration (FDA) focused on promoting development of safe and effective therapies for kidney disease.

Annual Reviews

KHI Annual Reviews

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2024 Annual Report April 1, 2025

  • 2024 Annual Report
  • The Kidney Health Initiative (KHI) is a public-private partnership among the American Society of Nephrology (ASN), the US Food and Drug Administration (FDA), and over 70 member companies and organizations committed to catalyzing innovation and the development of safe and effective patient-centered therapies for people with kidney diseases.
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2023 Annual Report May 3, 2024

  • 2023 Annual Report
  • The 2023 Annual Report offers an overview of KHI's achievements and initiatives over the past year. Review this report to explore KHI's publications, recorded webinars, and videos, including what to expect with ongoing initiatives in 2024. This report embodies KHI's commitment to catalyzing, communicating, convening, and collaborating safe and effective patient-centered therapies for people living with kidney diseases.
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2022 Annual Report March 27, 2023

  • 2022 Annual Report
  • KHI's Annual Report for 2022.
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2021 Annual Report April 21, 2022

  • 2021 Annual Report
  • This year, KHI hosted a successful virtual Eighth Annual Stakeholder Meeting that attracted 235 participants, completed six projects, and launched four new projects. KHI continued to have active volunteer participation in our workgroups, with 130 participants in 2021, and nine new publications representing KHI activities.
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2020 Annual ReviewApril 12, 2021

  • 2020 Annual Review
  • This year, KHI completed three projects, published four manuscripts, hosted five member townhalls, welcomed 10 new member organizations, and utilized the expertise of 167 volunteers from across the kidney community. This year's Annual Review highlights the impact of KHI and our member organizations on drug and device development and our response to COVID-19.
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2019 Annual Review December 6, 2019

  • 2019 Annual Review
  • This year, KHI completed three projects, published two manuscripts, hosted 200 attendees at the Seventh Annual Stakeholders Meeting, welcomed 13 new member organizations, and utilized the expertise of 152 volunteers from across the kidney community. This year's Annual Review highlights the impact of KHI and our member organizations on drug and device development.
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2018 Annual ReviewOctober 25, 2018

  • 2018 Annual Review
  • KHI's 2018 Annual Review
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2017 Annual ReviewNovember 1, 2017

  • 2017 Annual Review
  • 2017 Annual Review
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2016 Annual Review November 8, 2016

  • 2016 Annual Review
  • 2016 Annual Review
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2015 Annual ReviewNovember 5, 2015

  • 2015 Annual Review
  • 2015 Annual Review
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2012-2014 Inaugural ReviewOctober 31, 2014

  • 2012-2014 Inaugural Review
  • 2012-2014 Inaugural Review

Clinical Trial Endpoints

Outputs from projects related to the Strategic Priority of "Clinical trial endpoint and design".

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Proteinuria as an End Point in Clinical Trials of Focal Segmental GlomerulosclerosisOctober 3, 2024

  • Proteinuria as an End Point in Clinical Trials of Focal Segmental Glomerulosclerosis
  • The aim of this Kidney Health Initiative project was to evaluate potential end points for clinical trials in FSGS. Our focus is on the data supporting proteinuria as a surrogate end point.
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Developing Therapies for C3 Glomerulopathy Report of the Kidney Health Initiative C3 Glomerulopathy Trial Endpoints Work GroupSeptember 24, 2024

  • Developing Therapies for C3 Glomerulopathy Report of the Kidney Health Initiative C3 Glomerulopathy Trial Endpoints Work Group
  • The Kidney Health Initiative convened a panel of experts in C3G to (1) assess the data supporting the use of the prespecified trial end points as measures of clinical benefit and (2) opine on efficacy findings they would consider compelling as treatment(s) of C3G in native kidneys. Two subpanels of the C3G Trial Endpoints Work Group reviewed the available evidence and uncertainties for the association between the three prespecified end points—(1) proteinuria, (2) eGFR, and (3) histopathology—and anticipated outcomes. The full work group provided feedback on the summaries provided by the subpanels and on what potential treatment effects on the proposed end points they would consider compelling to support evidence of an investigational product's effectiveness for treating C3G.
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End Point Considerations for Clinical Trials in Enteric HyperoxaluriaMarch 7, 2024

  • End Point Considerations for Clinical Trials in Enteric Hyperoxaluria
  • Feature End Point Considerations for Clinical Trials in Enteric Hyperoxaluria Langman, Craig B.1; Assimos, Dean2; Blank, Melanie3; Calle, Juan4; Grauer, Andreas5; Kausz, Annamaria6; Milliner, Dawn7; Nazzal, Lama8; Smith, Kimberly9; Tasian, Greg10; Thompson, Aliza11; Wood, Kyle D.2; Worcester, Elaine12; Yang, Sixun13; Malley, Meaghan A.14; Knauf, Felix15; Lieske, John C.7,16; on behalf of the Rare Kidney Stone Consortium (RKSC) Kidney Health Initiative (KHI) Oxalosis and Hyperoxaluria Foundation Enteric Hyperoxaluria Workgroup (OHF EH Workgroup) Collaborators Author Information Clinical Journal of the American Society of Nephrology 18(12):p 1637-1644, December 2023. | DOI: 10.2215/CJN.0000000000000234 Buy Abstract Enteric hyperoxaluria is a medical condition characterized by elevated urinary oxalate excretion due to increased gastrointestinal oxalate absorption. Causative features include fat malabsorption and/or increased intestinal permeability to oxalate. Enteric hyperoxaluria has long been known to cause nephrolithiasis and nephrocalcinosis, and, more recently, an association with CKD and kidney failure has been shown. Currently, there are no US Food and Drug Administration–approved therapies for enteric hyperoxaluria, and it is unclear what end points should be used to evaluate the efficacy of new drugs and biologics for this condition.
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Patient Perspectives of Skeletal Muscle Cramping in Dialysis: a Focus Group StudyApril 10, 2023

  • Patient Perspectives of Skeletal Muscle Cramping in Dialysis: a Focus Group Study
  • Patient perspectives of skeletal muscle cramping in dialysis: a focus group study
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Conceptual Framework for Patient-Reported Outcome Measures in Clinical Trials of Skeletal Muscle Cramping Experienced in DialysisMay 13, 2022

  • Conceptual Framework for Patient-Reported Outcome Measures in Clinical Trials of Skeletal Muscle Cramping Experienced in Dialysis
  • The Kidney Health Initiative, a public-private partnership between the American Society of Nephrology and US Food and Drug Administration, convened a multidisciplinary workgroup to define a set of patient-reported outcome measures for use in clinical trials to test the effect of new dialysis devices, new KRTs, lifestyle/behavioral modifications, and medications on skeletal muscle cramping.
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Biomarkers Reported to be Useful in Acute Kidney InjuryApril 1, 2022

  • Biomarkers Reported to be Useful in Acute Kidney Injury
  • An overview of potential biomarkers, including what they can be used to measure and a summary of relevant studies. Each biomarker may have value for one or more of the following use cases.
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Pathophysiology and Treatment of Enteric HyperoxaluriaSeptember 8, 2020

  • Pathophysiology and Treatment of Enteric Hyperoxaluria
  • Enteric 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.
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Primary Hyperoxaluria: The Patient and Caregiver PerspectiveJuly 7, 2020

  • Primary Hyperoxaluria: The Patient and Caregiver Perspective
  • Living with primary hyperoxaluria—a rare genetic disease with excess oxalate production leading to frequent kidney stones, kidney impairment, and oxalosis—presents many challenges to patients, caregivers, and their families. Although the progression and severity of primary hyperoxaluria is variable, care for any child or adult with primary hyperoxaluria is an unusual strain to the family due to intensity of required medical care and associated financial hardship. To identify the concerns of the primary hyperoxaluria community, multiple in-person meetings were convened and a web-based survey was developed by families, the Oxalosis and Hyperoxaluria Foundation (OHF), the Kidney Health Initiative (KHI), and the American Institutes for Research. The patient and caregiver perspectives listed in this paper as well as the survey findings (Figure 1) were derived from the respondents from the survey and meetings and highlight the daily challenges and the great need for new therapies. The companion paper, "Endpoints for Clinical Trials in Primary Hyperoxaluria" by Milliner et al. presents a systematic analysis of available data to identify appropriate end points to assess the efficacy of potential therapies in clinical trials.
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Toward Patient-Centered Innovation: A Conceptual Framework for Patient-Reported Outcome Measures for Transformative Kidney Replacement DevicesApril 10, 2020

  • Toward Patient-Centered Innovation: A Conceptual Framework for Patient-Reported Outcome Measures for Transformative Kidney Replacement Devices
  • A Conceptual Framework for Patient-Reported Outcome Measures for Transformative Kidney Replacement Devices
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Endpoints for Clinical Trials in Primary HyperoxaluriaMarch 12, 2020

  • Endpoints for Clinical Trials in Primary Hyperoxaluria
  • Patients 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.
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Proteinuria Reduction as a Surrogate End Point in Trials of IgA NephropathyJanuary 11, 2019

  • Proteinuria Reduction as a Surrogate End Point in Trials of IgA Nephropathy
  • IgA 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 endpoints 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.
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Establishing Surrogate Kidney End Points for Lupus Nephritis Clinical TrialsSeptember 17, 2018

  • Establishing Surrogate Kidney End Points for Lupus Nephritis Clinical Trials
  • End points currently used in lupus nephritis (LN) clinical trials lack uniformity and questionably reflect long‐term kidney survival. This study was undertaken to identify short‐term end points that predict long‐term kidney outcomes for use in clinical trials.
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Clinical Trial End Points for Hemodialysis Vascular AccessMarch 7, 2018

  • Clinical Trial End Points for Hemodialysis Vascular Access
  • Hemodialysis vascular access is the "lifeline" for patients on hemodialysis. Unfortunately, because of its poor patency and significant complication rate, it is also the "Achilles heel" of hemodialysis. For example, the current unassisted arteriovenous fistula (AVF) maturation rate is only 40% between 6 and 9 months, and the 1-year unassisted patency for polytetrafluoroethylene grafts is 23%. Despite the magnitude of the clinical problem, relatively few new and effective therapies have been introduced into this field over the last two decades, resulting in a stagnation of vascular access care.
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Recommended Clinical Trial End Points for Dialysis CathetersMay 7, 2017

  • Recommended Clinical Trial End Points for Dialysis Catheters
  • Centralvenouscathetersareusedfrequentlyinpatientsonhemodialysisasabridgetoapermanentvascularaccess. Theyarepronetofrequentcomplications,includingcatheter-relatedbloodstreaminfection,catheterdysfunction, andcentralveinobstruction.Thereisacompellingneedtodevelopnewdrugsordevicestopreventcentralvenous catheter complications. We convened a multidisciplinary panel of experts to propose standardized definitions of catheter end points to guide the design of future clinical trials seeking approval from the Food and Drug Administration.
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Definitions and End Points for Interventional Studies for Arteriovenous Dialysis AccessApril 7, 2017

  • Definitions and End Points for Interventional Studies for Arteriovenous Dialysis Access
  • This paper is part of the Clinical Trial Endpoints for Dialysis Vascular Access Project of the American Society of Nephrology Kidney Health Initiative. The purpose of this project is to promote research in vascular access by clarifying trial end points which would be best suited to inform decisions in those situations in which supportive clinical data are required. The focus of a portion of the project is directed toward arteriovenous access.

Clinical Trial Infastructure

Outputs from projects related to the Strategic Priority of "Clinical trial infrastructure and developing the evidence base".

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Overcoming Barriers to Drug Development in Children with CKDMarch 7, 2024

  • Overcoming Barriers to Drug Development in Children with CKD
  • Like all sick children, children with CKD need access to safe and effective medicines that have been formulated and examined specifically for them. Despite legislation in the United States and the European Union that either mandates or incentivizes programs for children, conducting trials to advance the treatment of children continues to prove to be a challenge for drug developers. This is also the case for drug development in children with CKD, where trials face challenges in recruitment and completion and where there remains a substantial time lag between initial approval of a medicinal product for use in adults and completion of studies that result in the addition of pediatric-specific labeling for the same indication.
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Kidney Health Initiative ESKD Data Standards Project May 27, 2022

  • Kidney Health Initiative ESKD Data Standards Project
  • https://www.kidneymedicinejournal.org/article/S2590-0595(22)00111-X/fulltext
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Understanding and Overcoming the Challenges Related to Cardiovascular Trials Involving Patients with Kidney DiseaseApril 23, 2021

  • Understanding and Overcoming the Challenges Related to Cardiovascular Trials Involving Patients with Kidney Disease
  • Kidney disease is highly prevalent among patients with cardiovascular disease and is associated with worse cardiovascular outcomes. The evidence on which to base the optimal management of cardiovascular disease in patients with kidney disease is hampered by their continual exclusion from cardiovascular trials. This project aims to bring together a diverse group of public and private stakeholders in an effort to understand the barriers to including patients with kidney disease in cardiovascular trials and to identify potential strategies to overcome them.
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Pragmatic Trials in Maintenance Dialysis: Perspectives from the Kidney Health InitiativeJuly 1, 2016

  • Pragmatic Trials in Maintenance Dialysis: Perspectives from the Kidney Health Initiative
  • Pragmatic clinical trials are conducted under the real-world conditions of clinical care delivery.
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Pharmacokinetic Assessment in Patients Receiving Continuous RRT: Perspectives from the Kidney Health InitiativeJanuary 7, 2015

  • Pharmacokinetic Assessment in Patients Receiving Continuous RRT: Perspectives from the Kidney Health Initiative
  • 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.

COVID-19

Statements and resources on the impact of Coronavirus 2019 (COVID-19) on drug and device development within the kidney community.

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Including People with Kidney Diseases in COVID-19 Trials: Opportunity for Participation in Vaccine TrialsSeptember 14, 2020

  • Including People with Kidney Diseases in COVID-19 Trials: Opportunity for Participation in Vaccine Trials
  • Including people with kidney disease in COVID-19 vaccine trials will ensure that the effects of any vaccine candidate will be better understood in people with kidney disease as well as the general population.
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Making the Case for Change: Including People with Kidney Diseases in COVID-19 TrialsMay 15, 2020

  • Making the Case for Change: Including People with Kidney Diseases in COVID-19 Trials
  • Clinical trials often exclude people with kidney diseases. This means that 37 million people in the United States are rarely represented in the kind of research that advances change in treatment and care. The challenges that result from such exclusion are highlighted by the current COVID-19 crisis.
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Accelerating Technology Development During a Pandemic to Bring More People with Kidney Failure Home May 8, 2020

  • Accelerating Technology Development During a Pandemic to Bring More People with Kidney Failure Home
  • The COVID-19 pandemic is unmasking the shortcomings of in-center hemodialysis for people with kidney failure. Individuals with kidney failure who rely on in-center dialysis do not have the luxury of social distancing during a pandemic. In-center dialysis exposes people with kidney failure and healthcare workers to potential infection. Additionally, in-center hemodialysis patients are exposed to other discomforts and inconveniences associated with strict infection control and isolation policies necessitated by emergencies like pandemics.

Foundational Documents

Publications that laid the groundwork for KHI

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How the Kidney Health Initiative Catalyzes Innovation in a Dynamic EnvironmentDecember 6, 2019

  • How the Kidney Health Initiative Catalyzes Innovation in a Dynamic Environment
  • The kidney community today is not the same as it was when the Kidney Health Initiative (KHI) was founded in 2012. KHI, a public-private partnership between the American Society of Nephrology (ASN), the US Food and Drug Administration (FDA), and >100 members, has grown to the largest consortium in the kidney community. A perception within the community that there was an underrecognition that kidney disease was a serious public health issue and a lack of innovation in treating kidney diseases prompted KHI's formation >7 years ago (1). Today, that perception may be changing. Although many of the challenges are still the same, the kidney community has a renewed commitment and new tools to change the status quo. The kidney community has a unique opportunity as a result of increased industry investment and government attention to a significant public health need.
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Overcoming Barriers in Kidney Health—Forging a Platform for InnovationApril 1, 2016

  • Overcoming Barriers in Kidney Health—Forging a Platform for Innovation
  • Innovationinkidneydiseasesisnotcommensuratewiththeeffectofthesediseases on human health and mortality or innovation in other key therapeutic areas.
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Fostering Innovation, Advancing Patient Safety: The Kidney Health InitiativeSeptember 1, 2013

  • Fostering Innovation, Advancing Patient Safety: The Kidney Health Initiative
  • To 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.

Government Collaboration

Outputs from projects related to the Strategic Priority of "Closer collaboration with FDA and other government agencies".

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Roadmap for Accelerating the Development of Biomarkers for Acute Kidney InjuryApril 1, 2022

  • Roadmap for Accelerating the Development of Biomarkers for Acute Kidney Injury
  • The Kidney Health Initiative (KHI) developed this roadmap in response to the significant unmet need for acute kidney injury (AKI) biomarkers to better inform patient care and therapeutic development.
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Hemodiafiltration to Address Unmet Medical Needs ESKD PatientsSeptember 7, 2018

  • Hemodiafiltration to Address Unmet Medical Needs ESKD Patients
  • Hemodiafiltration 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.
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Regulatory Considerations for Hemodiafiltration in the United StatesSeptember 7, 2018

  • Regulatory Considerations for Hemodiafiltration in the United States
  • Online 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.
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Clinical and Regulatory Considerations for Central Venous Catheters for HemodialysisAugust 1, 2018

  • Clinical and Regulatory Considerations for Central Venous Catheters for Hemodialysis
  • Central 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.
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FDA Regulatory Perspectives for Studies on Hemodialysis Vascular AccessAugust 7, 2017

  • FDA Regulatory Perspectives for Studies on Hemodialysis Vascular Access
  • In 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'smissionistofosterdevelopmentoftherapiesbycreatingacollaborativeenvironmentwheretheUSFood andDrugAdministrationandthegreaternephrologycommunitycaninteracttooptimizeproductevaluation.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.

Member Town Halls

Slide decks from member town hall webinars

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Patient Preferences in Regulatory Decision Making August 5, 2020

  • Patient Preferences in Regulatory Decision Making
  • This Member Town Hall will cover integrating patient preferences into regulatory decision making and will provide an update on the Building Capacity to Incorporate Patient Preferences into the Development of Innovative Alternatives to Renal Replacement Therapy (RRT) project.
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Clinical Trials in COVID-19July 15, 2020

  • Clinical Trials in COVID-19
  • Member Town Hall on Conducting Clinical Trials in COVID-19
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Membership Town Hall June 10, 2020

  • Membership Town Hall
  • June Membership Town Hall Webinar

Patient and Family Partnership

Outputs from projects related to the Strategic Priority of "Advancement of patient and family partnership and funding of kidney disease".

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Patient-reported Outcomes in Hemodialysis Vascular Access: A Call to ActionMay 25, 2021

  • Patient-reported Outcomes in Hemodialysis Vascular Access: A Call to Action
  • The overall goal of this project is to further the development of patient-reported tools that measure the impact that vascular access has on the functioning quality of life of patients on hemodialysis.
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Fostering Innovation in Symptom Management among Hemodialysis Patients: Paths Forward for Insomnia, Muscle Cramps, and FatigueOctober 19, 2018

  • Fostering Innovation in Symptom Management among Hemodialysis Patients: Paths Forward for Insomnia, Muscle Cramps, and Fatigue
  • Individuals 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.
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Symptom Prioritization among Adults Receiving In-Center Hemodialysis May 7, 2018

  • Symptom Prioritization among Adults Receiving In-Center Hemodialysis
  • First publication from the Prioritizing Symptoms of ESRD Patients for Developing Therapeutic Interventions Project
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Perspectives from the Kidney Health Initiative on Advancing Technologies to Facilitate Remote Monitoring of Patient Self-Care in RRTOctober 7, 2017

  • Perspectives from the Kidney Health Initiative on Advancing Technologies to Facilitate Remote Monitoring of Patient Self-Care in RRT
  • Telehealthandremotemonitoringofapatient'shealthstatushasbecomemorecommonplaceinthelastdecadeand has been applied to conditions such as heart failure, diabetes mellitus, hypertension, and chronic obstructive pulmonarydisease.
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Stimulating Patient Engagement in Medical Device Development in Kidney Disease: A Report of a Kidney Health Initiative Workshop April 10, 2017

  • Stimulating Patient Engagement in Medical Device Development in Kidney Disease: A Report of a Kidney Health Initiative Workshop
  • American Journal Of Kidney Disease: Special Report

Press Releases

Announcements about KHI from the American Society of Nephrology

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KIDNEY HEALTH INITIATIVE URGES INVESTIGATORS TO INCLUDE PEOPLE WITH KIDNEY DISEASES IN CLINICAL TRIALS FOR CORONAVIRUS 2019 (COVID-19) THERAPIESJune 9, 2020

  • KIDNEY HEALTH INITIATIVE URGES INVESTIGATORS TO INCLUDE PEOPLE WITH KIDNEY DISEASES IN CLINICAL TRIALS FOR CORONAVIRUS 2019 (COVID-19) THERAPIES
  • Clinical trials often exclude people with kidney diseases. This practice could have significant consequences, if continued, during the Coronavirus – 2019 (COVID-19) pandemic and for the 37 million Americans with kidney diseases who are at high risk of severe disease.
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KIDNEY HEALTH INITIATIVE COMPLETES PROJECT FOCUSED ON CLINICAL TRIAL END POINTS FOR PRIMARY HYPEROXALURIAMarch 17, 2020

  • KIDNEY HEALTH INITIATIVE COMPLETES PROJECT FOCUSED ON CLINICAL TRIAL END POINTS FOR PRIMARY HYPEROXALURIA
  • The Kidney Health Initiative (KHI), in partnership with the Oxalosis and Hyperoxaluria Foundation (OHF), concluded a collaborative effort to evaluate efficacy end points for clinical trials in primary hyperoxaluria.
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KIDNEY HEALTH INITIATIVE ANNOUNCES NEW BOARD MEMBERSJanuary 2, 2020

  • KIDNEY HEALTH INITIATIVE ANNOUNCES NEW BOARD MEMBERS
  • Today, seven new members were named to the Kidney Health Initiative (KHI) Board of Directors. KHI is a public-private partnership between the American Society of Nephrology (ASN) and the US Food and Drug Administration (FDA).
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KIDNEY HEALTH INITIATIVE LAUNCHES PROJECT TO MEASURE PATIENT PREFERENCES FOR NOVEL KIDNEY DEVICES October 24, 2019

  • KIDNEY HEALTH INITIATIVE LAUNCHES PROJECT TO MEASURE PATIENT PREFERENCES FOR NOVEL KIDNEY DEVICES
  • The US Food and Drug Administration (FDA) has awarded a contract to the Kidney Health Initiative (KHI) to study patient preferences for innovative renal replacement therapy (RRT) devices. The three-year project, "Building Capacity to Incorporate Patient Preferences into the Development of Innovative Alternatives to Renal Replacement Therapy" will capture patient preference and risk tolerance data from people with kidney failure to drive innovations in RRT.
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KIDNEY HEALTH INITIATVE PROVIDES NEW RESOURCES TO PATIENTS AND INNOVATORS DEVELOPING AN ARTIFICIAL KIDNEY September 4, 2019

  • KIDNEY HEALTH INITIATVE PROVIDES NEW RESOURCES TO PATIENTS AND INNOVATORS DEVELOPING AN ARTIFICIAL KIDNEY
  • The Kidney Health Initiative (KHI), today announced the availability of two new resources to advance the global pursuit of an artificial kidney for use in humans. The US Department of Health and Human (HHS)'s Advancing American Kidney Health initiative made developing an artificial kidney a national priority through KidneyX and its Redesign Dialysis prize competition. KHI's Technology Roadmap for Innovative Alternatives to Renal Replacement Therapy (RRT Technology Roadmap) established the foundational strategy for KidneyX and details the basic science requirements of an artificial kidney.
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Kidney Patients are Neglected in Clinical Trials July 9, 2019

  • Kidney Patients are Neglected in Clinical Trials
  • The Kidney Health Initiative, the American Society of Nephrology's public-private partnership with the US Food and Drug Administration, addresses this issue through its "Overcoming Barriers to Including Kidney Disease Patients in Cardiovascular Trials". The project aims to understand the barriers to involving patients with kidney diseases into cardiovascular trials, with a focus on patients with advanced chronic kidney disease (stage 4) and end-stage renal diseases and identify strategies to overcome these challenges. The workgroup intends to submit their findings to a peer-reviewed medical journal in Summer 2019.
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AMERICAN SOCIETY OF NEPHROLOGY ANNOUNCES 2019-2021 KIDNEY HEALTH INITIATIVE CO-CHAIRNovember 1, 2018

  • AMERICAN SOCIETY OF NEPHROLOGY ANNOUNCES 2019-2021 KIDNEY HEALTH INITIATIVE CO-CHAIR
  • The American Society of Nephrology (ASN) today announced former ASN President Raymond C. Harris, Jr., MD, FASN, will serve as co-chair for its Kidney Health Initiative (KHI). Harris, a professor of medicine, molecular physiology, and biophysics, is Director of the Vanderbilt Center for Kidney Disease and former chief of the nephrology division of Vanderbilt University's Medical Center in Nashville, Tenn.
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AMERICAN SOCIETY OF NEPHROLOGY'S KIDNEY HEALTH INITIATIVE ANNOUNCES RELEASE OF "TECHNOLOGY ROADMAP" TO SPUR KIDNEY DIALYSIS INNOVATIONSOctober 25, 2018

  • AMERICAN SOCIETY OF NEPHROLOGY'S KIDNEY HEALTH INITIATIVE ANNOUNCES RELEASE OF "TECHNOLOGY ROADMAP" TO SPUR KIDNEY DIALYSIS INNOVATIONS
  • In the US there are 570,000 patients with very advanced kidney disease who require dialysis. This treatment, however, as currently administered, has changed little in the 60 years since it was introduced. While life-saving, it usually leaves patients with substantial morbidity and a shortened life expectancy. In the search for new ways to support these patients, the American Society of Nephrology's (ASN) Kidney Health Initiative (KHI) today went live with its Technology Roadmap for Innovative Approaches to Renal Replacement Therapy (RRT). Developed by a multidisciplinary team of experts led by Joseph V. Bonventre, MD, PhD, the release comes during ASN's Kidney Week 2018 currently underway in San Diego, California.