The Kidney Health Initiative (KHI) is a public-private partnership between the American Society of Nephrology (ASN), US Food and Drug Administration (FDA), and all major stakeholders in the kidney community (patients, healthcare professionals, members of industry and government). KHI is the largest consortium in the kidney community and is focused on addressing barriers to the development of new drugs, devices and biologics for people living with kidney disease. KHI's Board of Directors and project workgroups discuss and develop solutions for barriers as they are identified by the membership and community. Solutions include but are not limited to opportunities to elucidate clinical trial endpoints, improve clinical trial design and execution, to develop diagnostic markers and patient registries, to create avenues for closer collaboration with the US Food and Drug Administration (FDA) and other stakeholders, and to advance awareness and inclusion of people living with kidney diseases into drug, device and biologic development. The application will outline support for the future roadmaps and projects, expansion of the patient and family partnership and KHI infrastructure, such as the project submission process and annual stakeholders meeting. The current grant proposal plans to build upon the initial successes of the KHI and take our collaboration with the FDA to the next level in terms of organization, scope and impact.

Public Health Relevance

The Kidney Health Initiative (KHI) is a public-private partnership between the American Society of Nephrology (ASN), the US Food and Drug Administration (FDA), and the kidney community whose mission is to catalyze innovation and the development of safe and effective patient-centered therapies for people living with kidney diseases. KHI includes all the major stakeholders in this field (patients, healthcare professionals, members of industry and government). KHI is a pre-competitive forum where all the players affiliated with kidney disease can come together to strategize and participate in workgroups that will develop roadmaps, white papers, workshops and data standards. KHI deliverables provide recommendations and direction for any individual, company, or organization to use for the development of new therapies. For more information on KHI, please visit www.kidneyhealthinitiative.org.

Agency
National Institute of Health (NIH)
Institute
Food and Drug Administration (FDA)
Type
Research Demonstration and Dissemination Projects (R18)
Project #
2R18FD005283-06
Application #
9965420
Study Section
Special Emphasis Panel (ZFD1)
Program Officer
Lauda, Mark
Project Start
2014-09-01
Project End
2024-08-31
Budget Start
2019-09-01
Budget End
2020-08-31
Support Year
6
Fiscal Year
2019
Total Cost
Indirect Cost
Name
American Society of Nephrology, Inc.
Department
Type
DUNS #
184075885
City
Washington
State
DC
Country
United States
Zip Code
20005
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