Kidney Health Initiative (KHI)

KHI Mission

Kidney Health Initiative

To advance scientific understanding of the kidney health and patient safety implications of new and existing medical products and to foster development of therapies for diseases that affect the kidney by creating a collaborative environment in which FDA and the greater nephrology community can interact to optimize evaluation of drugs, devices, biologics, and food products.

KHI Announces New Members of the KHI Board of Directors

On September 13, the KHI Board of Directors met and approved the 2017 Slate put forth by the Nominating Committee. KHI would like to congratulate the following renewed and new members of the KHI Board of Directors.

Renewing Members

Healthcare Professional

  • Katherine R. Tuttle, MD, FASN (2019) – American Society of Nephrology


  • Joseph Muldoon (2018) – Fast BioMedical
  • Mark Costanzo (2018) – Fresenius Medical Care
  • Mahesh Krishnan, MD, MPH, MBA, FASN (2019)- DaVita
New members

Patient/ Patient Advocate

  • David Baron, PhD (2019) – PKD Foundation


  • Markus Ketteler, MD (2019) – ERA/EDTA

CMS Representative

  • Jesse Roach, MD (2019) – Centers for Medicare and Medicaid Services

In addition to welcoming our new Board Members, we would like to thank the Nominating Committee for producing the Board of Directors Slate:

  • Paul Conway
  • Alan S. Kliger, MD
  • Carolyn Y. Neuland, PhD
  • Prabir Roy-Chaudhury, MD, PhD, FASN
  • James A. Sloand, MD, FASN
  • Ex-Officio: Jonathan Himmelfarb, MD, FASN

Furthermore, KHI leadership would like to thank KHI's founding Co-Chair, Patrick Archdeacon, MD, for his service to KHI. Dr. Archdeacon has accepted a new position in the Division of Metabolism and Endocrinology Products within Center for Drug Evaluation and Research (CDER) at FDA. Due to his new role, Dr. Archdeacon will no longer serve as Co-Chair of the KHI Board of Directors. The Board of Directors and KHI staff thank Dr. Archdeacon for his commitment, effort, and support in KHI.

Kristen Miller, PharmD from the FDA Office of Medical Policy is serving as KHI's main point of contact with FDA during the transition. Aliza Thompson, MD a Medical Officer in the Division of Cardiovascular and Renal Products at CDER and Carolyn Y. Neuland, PhD, the Chief of the Renal Devices Branch in the Division of Reproductive, Gastro-Renal and Urological Devices at the Center for Devices and Radiological Health (CDRH) have also committed their support to the KHI leadership and staff during the transition.

If you have any questions, please contact KHI staff at

Open Call for Workgroups

The following is a list of current opportunities for KHI members to volunteer their service on a project workgroup. Click on the title for more information and details on how to volunteer.

Involvement in workgroups is on a voluntary basis with no compensation provided. All workgroup members are required to submit an online disclosure form with their application.

KHI Attends the White House Organ Summit

KHI is pleased to support President Barack Obama's call to action through its attendance at the White House Organ Summit on Monday, June 13. This Summit will examine ways to improve the outcomes for individuals waiting for organ transplants and support living donors in addition to improving kidney patient care options and transplantation access.

KHI has submitted the following commitment statement in support of the White House Initiative

The Kidney Health Initiative, a public-private partnership established by the U.S. Food and Drug Administration and the American Society of Nephrology and composed of more than 75 member organizations, will initiate the development of a roadmap that will describe scientific, technical, and regulatory milestones needed to achieve the goal of creating a bioartificial or bioengineered alternative to dialysis as renal replacement therapy. The roadmap will also consider challenges, provide "state of the art" expectations for entrepreneurs and other technology developers, and spur innovation in producing functioning kidney replacements by engaging stakeholders, identifying research priorities to alleviate critical knowledge gaps, and advancing the science of alternatives to dialysis.

The roadmap was presented as a project proposal at the Fourth Annual KHI Stakeholders Meeting in May 2016. The proposal can be viewed on the KHI Meetings Page.

KHI Announces New Members of the Patient and Family Partnership Council (PFPC)

The KHI Patient and Family Partnership Council (PFPC) was established in May 2015. KHI is pleased to welcome three new members to the PFPC, fulfilling the organizational structure as a 10 member Council.

Pamela Duquette, is the mother of a child with FSGS and represents NephCure International.

Nichole Jefferson has experienced both peritoneal and hemo-dialysis treatments. Nichole received a kidney transplant in the summer of 2008.

David White has experienced in-center hemo-dialysis, in-center nocturnal hemo-dialysis, and peritoneal dialysis. Dave received a kidney transplant in the summer of 2015.

To learn more about the PFPC or its members, please visit the PFPC page.

Fourth Annual KHI Stakeholders Meeting

The Fourth Annual KHI Stakeholders Meeting took place at the DoubleTree by Hilton Hotel Washington DC- Silver Spring in Silver Spring, MD on May 25-26, 2016. The Stakeholders Meeting brought together our diverse membership from the kidney community to connect members across different fields, share ideas, collect feedback, and collaborate on new and proposed projects.

Please visit the KHI Meetings Page for more information on the Fourth Annual KHI Stakeholders Meeting.

KHI Annual Report 2014-2015

On behalf of the Board of Directors, we would like to thank the KHI membership for their participation in KHI, which has seen its membership grow from 47 organizations in September 2013, to more than 75 organizations in December 2015. The membership has worked diligently through KHI to improve patient safety and promote the development of optimal therapies for diseases that affect kidneys and the quality of life for millions of people.

View KHI's 2014-2015 Annual Report.

View the KHI Inaugural Review 2012-2014.

KHI Publications

Learn More

If you have any questions about KHI, or would like more information about becoming a member, please contact