KHI’s Collaborative Approach Identifies Priorities and Opportunities That Will Have an Impact on Kidney Disease

Despite the large number of Americans affected by kidney disease, few new drugs have been approved to treat it in the past decade. To address this issue and to ensure high-quality care for every patient with kidney disease, the American Society of Nephrology (ASN) and the U.S. Food and Drug Administration (FDA) formed a public–private partnership called the Kidney Health Initiative (KHI) in September 2012 to enhance patient safety and foster innovation.

Over the past 2 years, KHI has made advances toward fulfilling its mission through a collaborative partnership with the kidney community. In particular, the KHI board of directors would like to thank its 68 members for their commitment, ideas, and participation in the annual stakeholders’ meetings and in project workgroups.

As a member-driven initiative, KHI meets its mission and objectives through the completion of projects proposed by members across the kidney community, including the FDA, organizations of patients, organizations of health professionals, research institutions, and members of industry, including small and large pharmaceutical, biotechnology, and device companies along with dialysis organizations. The focus of KHI is to promote innovation within the kidney space, but also core to its mission is innovation within the process of project selection, work group constitution, and deliverables.

These innovations include (a) creation of a precompetitive, multidisciplinary platform where all the stakeholders can come together and interact, (b) special emphasis on patients and their views on how to improve kidney care, (c) an opportunity for all interested members to participate in the project work groups, (d) collaborative relationships with federal agencies such as the FDA, the Centers for Medicare and Medicaid Services, the National Institutes of Health, and the Centers for Disease Control, and (e) emphasis on the project deliverables being enablers such as white papers, workshops, and data standards that would likely allow for a long-term impact on innovation by creating a durable and well-accepted “pathway for innovation.”

Currently, five active ongoing projects within KHI are focusing on a wide range of kidney-relevant topics, ranging from continuous renal replacement therapy pharmacokinetics to vascular access to lupus nephritis (Table 1). In addition, the KHI board recently endorsed an additional four projects on data standards for diabetic nephropathy, pragmatic trials in nephrology, regulatory policies and positions for device approval, and advancing technologies for patient self-care in the setting of renal replacement therapy. The deliverables from these nine projects will include workshops, white papers, and data standards. We believe that these outputs will then serve as a platform (as an enabler) for further much-needed progress in these areas.

Table 1.


The identification of a set of well-defined, scientifically validated clinical trial endpoints for lupus nephritis and dialysis vascular access, for example, could greatly facilitate clinical trials of innovative therapies for both these conditions, which would likely translate into improved care for patients with chronic kidney disease and ESRD.

KHI’s early progress gives kidney patients hope for a better tomorrow and emphasizes that real advances can be made through a collaborative approach that brings together all the stakeholders in the kidney space.

KHI looks forward to continued growth and interaction among its diverse members. To obtain additional information or discuss KHI and its projects, please contact the KHI staff at