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 Project Spotlight

The KHI Workgroup, "Understanding and Overcoming the Challenges to Involving Patients with Kidney Disease in Cardiovascular Trials" has made significant progress. In fact, the group 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.

The surveys will close on Monday, January 8, 2018. 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 call for workgroups is now closed. There are no workgroups currently accepting volunteers.

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.

Project Submission: Cycle IX

The project portal is now closed. In order to review and comment on current proposals please visit the Project Proposal page.

If you have any questions, or would like to discuss an idea before submission, please don't hesitate to contact us at

Save the Date: Sixth Annual KHI Stakeholders Meeting

Join us on May 14-15, 2018 in Silver Spring, Maryland for the Sixth Annual KHI Stakeholders Meeting. The meeting will start at 4:00pm on Monday, May 14 and end at 3:00pm on Tuesday, May 15. More information, including the agenda, will be posted in the coming months. We look forward to seeing all KHI members at this annual meeting.

KHI Publications

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