KHI Program Strategies

Priority Area

Current Projects

Completed Projects

Collaboration and Partnership:
Our goal is to support CDER, CDRH, CBER and CFASN in their mission to "protect the public health" by convening the community, including other federal agencies, to inform regulatory science and decision making. We accomplish this by promoting the inclusion of people with kidney diseases and appropriate measurement of kidney function in clinical trials conducted outside of nephrology.
  • Including People with Kidney Diseases in COVID-19 Clinical Trials
  • Conduct of Clinical Trials (Endpoints, Design, Diversity and Inclusion, Workforce and Training):
    We focus on identifying and promoting better clinical trial practices both immediately and for future trials by educating and supported academics and workforce training of nephrology trialists.
  • Drug Development in Children with Kidney Diseases

  • Endpoints for Enteric Hyperoxaluria Clinical Trials

  • Global ESKD Data Standards

  • Surrogate Endpoints in FSGS

  • Endpoints for C3 Glomerulopathy (C3G)

  • Clinical Trial Endpoints for Dialysis Vascular Access

  • Endpoints for Primary Hyperoxaluria Clinical Trials

  • Data Harmonization in Kidney Transplantation

  • Data Standards in Diabetic Kidney Disease

  • Outcome Measures in Lupus Nephritis Trials

  • Pragmatic Trials in Dialysis: Challenges and Opportunities

  • Pharmacokinetics in Patients Receiving Continuous Renal Replacement Therapy

  • Regulatory Policies and Positions Affecting Device Approval in the US

  • Pharmacokinetics in Patients Receiving Continuous Renal Replacement Therapy

  • Patient-Reported Outcome Measures for Novel Renal Devices

  • Surrogate Endpoints in IgA Nephropathy

  • Involving Kidney Patients in Cardiovascular Trials

  • Patient Engagement and Patient-Centered Tools for Regulatory Use:
    We aim to cultivate patient engagement and partnerships to ensure participants in clinical trials reflect the community most impacted by the disease. We do so by developing tools and best practices that facilitate the collection of patient preferences, patient-reported outcomes, and patient-prioritized clinical outcomes in clinical trials.
  • Incorporating Patient Preference into the Development of Novel Kidney Replacement Therapy

  • Patient Reported Outcomes for Muscle Cramping

  • Advancing Technologies to Facilitate Remote Management of Patient Self-Care in Kidney Replacement Therapy

  • Prioritizing Symptoms of Kidney Failure Patients for Developing Therapeutic Interventions

  • Patient Preferences for Device Development

  • Patient Reported Outcomes for Vascular Access

  • Real-World Evidence and Roadmapping:
    Our goal is to generate recommendations and frameworks to support the development and collection of real-world evidence for regulatory use (including safety and efficacy) and develop roadmaps for future medical devices, diagnostics, or therapeutics that include patient centered endpoints and regulatory and reimbursement pathways.
  • Developing a Roadmap to Accelerate the Expansion of AKI Biomarkers for Drug Development
  • A Guide to Regulatory Resources for the Product Developer

  • Innovations in Fluid Management

  • Patient Edition of Technology Roadmap for Innovative Approaches to Kidney Replacement Therapy

  • Technology Roadmap for Innovative Approaches to Kidney Replacement Therapy

  • Clinical Trial Design to Support Innovative Approaches to Kidney Replacement Therapy