Frequently Asked Questions
1. What is the Kidney Health Initiative (KHI)?
The Kidney Health Initiative was established in September 2012 under a Memorandum of Understanding between the American Society of Nephrology (ASN) and US Food and Drug Administration (FDA).
2. Why was KHI established?
Up to 26 million Americans have kidney disease, and more than 570,000 Americans have kidney failure, also known as end-stage kidney disease (ESKD). In the past decade, too few new drugs have been approved to treat kidney disease. Moreover, certain products on the market treating other organs and conditions may have adverse side effects on kidney health, raising serious patient safety concerns. There are also significant racial and ethnic health disparities at every stage of kidney disease. As the public health implications and economic burdens of kidney disease continue to grow, the care and safety of these patients warrant increased attention. KHI will help the nephrology community collaborate to improve patient safety and develop novel therapies.
3. What is the mission of KHI?
The mission of KHI is 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 the FDA and the greater nephrology community can interact to optimize the evaluation of drugs, devices, biologics, and food products.
4. Who can join KHI?
KHI is a collaborative environment for all stakeholders in the kidney community to help foster development of optimum therapies for diseases that affect the kidney. KHI members may include:
- Patient organizations
- Health professional organizations
- Research Institutions
- Pharmaceutical and biotechnology companies
- Device manufacturers
- Dialysis providers
- US and international government agencies
Please refer to the membership page for information about the dues structure.
5. How can my organization join KHI?
If you are interested in joining KHI, please visit the membership page for more information on the application process.
6. What is a KHI Pioneer Member?
Any organization that joined KHI between September 27, 2012 and December 31, 2013 is designated as a visionary "Pioneer Member" for the duration of the organization's participation in KHI.
7. What are the KHI member benefits?
All members will be involved in the selection and execution of projects, including co-authoring white papers, collaborating to leverage previously conducted and ongoing clinical studies, research infrastructure, and databases, as well as promoting dialogue on kidney health pertaining to drug, device, biologics, and food product development, evaluation, and safety.
KHI is dedicated to creating a transparent infrastructure and processes that facilitate collaboration and communication among the greater nephrology community and FDA. This includes establishing an open and efficient mechanism for encouraging and evaluating potential projects members submit to KHI, and to ensuring objective evaluation of those suggestions.
8. Where does the funding for KHI come from?
KHI is funded through dues paid by KHI members. No ASN membership dues are allocated to the KHI budget.
In addition, KHI receives funding from the U.S. Food and Drug Administration (FDA) through a five year, renewable R18 grant. The initial award ($430,650) was intended to support KHI activities during the budget period September 1, 2014 – August 31, 2015. Through this grant, FDA can provide additional support to KHI up to $500,000 per year through August 31, 2019.