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.

Public Comment Period

Stakeholders from around the Kidney Community are invited to comment on the draft version of the Technology Roadmap for Innovative Approaches to Renal Replacement Therapy during a public comment period running until September 14.

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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.

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 khi@asn-online.org.