KHI Publications

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KHI Publications

View and download publications produced by KHI workgroups.

Signature Initiatives

Publications that exemplify the strengths of KHI

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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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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 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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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.

Foundational Documents

Publications that laid the groundwork for KHI

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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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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.

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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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