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.

Call for Nominations for the KHI Board of Directors

The KHI Nominating Committee would like to announce its annual call for nominations for the KHI Board of Directors. The organizational structure of the Board of Directors includes patients or patient advocates, representative from commercial entities, government liaisons, and healthcare professionals. The KHI Nominating Committee will evaluate candidates with a focus on diversity, which includes, but is not limited to, age and experience, ethnicity, and gender.

We encourage everyone to review the Call for Nominations. Eligible candidates should apply or be nominated by Thursday, August 9, 2018.

Thank you for considering this opportunity to serve KHI and the broader kidney community. If you have any questions about the call for nominations, please contact the KHI Nominating Committee, or KHI staff, Ms. Melissa West, KHI Project Director at, or Mr. Rick Kempinski, KHI Manager at

KHI Project Spotlight

The KHI Workgroup, "Understanding and Overcoming the Challenges to Involving Patients with Kidney Disease in Cardiovascular Trials" has developed two surveys to better assess why kidney patients are often excluded from cardiovascular clinical trials. Specifically, one survey is for trial sponsors/other stakeholders, and the other is for patients and care-partners.

We are pleased to announce that the surveys are now open! Depending on the stakeholder-type with which you mostly closely identify, we encourage you to take the most appropriate survey listed below.

Once the results of the surveys are collated, the group plans to analyze the results in a white paper, as well as a host a meeting with experts to identify solutions to the barriers identified.

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.

The Sixth Annual KHI Stakeholders Meeting

The Sixth Annual KHI Stakeholders Meeting was held May 14-15, 2018 in Silver Spring, Maryland. Audio and video records of the meeting are now available here.

KHI Publications

Clinical Trial Endpoints for Dialysis Vascular Access
Regulatory Policies and Positions Affecting Device Approval in the US: Tools to Assess the Process and Foster Device Development for Patients with Kidney Disease

KHI Annual Report 2017

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 80 organizations in October 2017. 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 2017 Annual Report.
  • View KHI's 2016 Annual Report.
  • View KHI's 2015 Annual Report.
  • View the KHI Inaugural Review 2012-2014.

Learn More

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