Kidney Health Initiative Expands Offerings

The Kidney Health Initiative (KHI) is a public-private partnership founded in September 2012 by the American Society of Nephrology and the U.S. Food and Drug Administration (FDA). Since its inception, KHI has steadily increased its membership to more than 70 member organizations.

KHI advances its mission through a portfolio of innovative, collaborative, and member-driven projects. The collaborative will complete six of its 13 initial projects by the end of 2015:

  • Pharmacokinetics in Patients Receiving Continuous Renal Replacement Therapy
  • Outcome Measures in Lupus Nephritis
  • Promoting Kidney Health and Innovative Treatments for Kidney Disease: Barriers and Potential Solutions
  • Pragmatic Trials in Dialysis: Challenges and Opportunities
  • Regulatory Policies and Positions Affecting Device Approval in the US: Tools to Assess the Process and Foster Device Development for Patients with Kidney Disease
  • Workshop to Elucidate Role of Patient Preferences in Support of CDRH Regulatory Actions in Kidney Disease

Innovation in kidney disease is substantially lagging behind other specialty areas, despite the enormous toll that chronic kidney disease and end stage kidney disease exacts on its patients. No one stakeholder—be it regulatory, payer, industry, patients, or health professionals—has the capability and resources to reverse this approximately 60-year trend. Rather, the diverse membership of KHI, including members from each of the critical stakeholders, is in an excellent position to pose solutions to these critical barriers and serve as a platform for their implementation.

The KHI “Promoting Kidney Health and Innovative Treatments for Kidney Disease: Barriers and Potential Solutions” workgroup helps frame the strategic priorities that will stimulate innovation in kidney disease and identifies several transformative initiatives to support. Please look for their publication in the coming months.

KHI hosted a workshop titled “Understanding Patients’ Preferences: Stimulating Medical Device Development in Kidney Disease” in August 2015. The workshop was organized by the KHI “Workshop to Elucidate Role of Patient Preferences in Support of CDRH Regulatory Actions in Kidney Disease” workgroup, and balanced education with small group breakout discussions, allowing patients to share their ideas directly with the FDA, scientists, doctors, nurses, and technicians. The KHI workshop was attended by more than 100 participants including over 50 patients, care partners, and family members.

“KHI’s early progress gives kidney patients hope for a better tomorrow and emphasizes that real advances can be made through a collaborative approach that brings together all the stakeholders in the kidney space,” observed Prabir Roy-Chaudhury, MD, PhD, FASN, who co-chairs the KHI Board of Directors along with Patrick Archdeacon, MD, a medical officer in the Office of Medical Policy with the Center for Drug Evaluation and Research (CDER) at the FDA.

To advance efforts to improve patient safety and promote the development of therapies for diseases that affect the kidneys, KHI established a Patient and Family Partnership Council (PFPC) in 2015. PFPC has worked closely with the KHI Board of Directors, interacting, advising, and making recommendations on KHI member proposals, projects, and efforts so that patient involvement is meaningful and effective.

The KHI membership thanks the KHI Board of Directors for their leadership and service. In particular, the membership recognizes four leaders who are stepping off the KHI Board of Directors at the end of 2015:

  • Nancy M. Gallagher, RN, CNN
  • Kristine Kuus, PhD
  • Sam M. Pederson

KHI would also like to recognize the new members of the KHI Board of Directors who will begin serving in 2016:

  • Paul T. Conway
  • Wendy St. Peter, PharmD
  • Roberta L. Wager, MSN, RN
  • Alexander S. Yevzlin, MD

To obtain additional information or to discuss KHI, the initiative’s projects, or the KHI PFPC, please contact the KHI staff at