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.

RRT Roadmap

Thanks to all the stakeholders who commented on the Technology Roadmap for Innovative Approaches to Renal Replacement Therapy. The public comment period has closed and version 1.0 will be released during ASN Kidney Week 2018. Click the link below to read the draft version and learn more about this project.

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KHI at ASN Kidney Week 2018

KHI will hold an Open House during Kidney Week to meet with prospective and current members. Similar to past Open Houses, the event will be an informal networking event with brief comments by the co-chairs. A light lunch will be provided.

Date: Thursday, October 25
Time: 12:30 PM – 1:45 PM
Location: Marriott Marquis, San Diego Marina, 333 West Harbor Drive, Marina Ballroom D

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Patient Resources

Learn more about KHI Patient & Family Partnership Council (PFPC) and read the latest edition of the KHI PFPC newsletter here.

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 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.

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.

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