This section describes basic and clinical research activities supported or sponsored by the Federal government.
- Centers for Disease Control and Prevention
- Food and Drug Administration
- National Institute of Diabetes and Digestive and Kidney Diseases
- Veterans Affairs
Centers for Disease Control and Prevention (CDC)
CDC conducts numerous epidemiologic studies to determine risk factors for incidence and progression of chronic kidney disease (CKD) and to research the burden of CKD in the general population and in special populations (e.g., mortality among people with CKD and incidence of kidney failure among people with diabetes, among other topics).
CDC, in collaboration with the Veterans Affairs—Puget Sound Health Care System, is using CKD progression models to evaluate the natural history of the disease. The study aims to 1) estimate the rate of progression through the stages of CKD and the development of complications; 2) look at comorbidities and risk factors associated with disease progression and rate of progression to kidney failure; and 3) develop a comorbidity index to serve as prognostic tool in identifying CKD patients at high risk of progression to kidney failure.
CDC’s Longitudinal Study of Markers of Kidney Disease is a collaboration with the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health (NIH/NIDDK) to investigate using new kidney disease markers to diagnose early kidney function decline. The project aims to validate new kidney markers as early indicators of kidney disease to 1) improve diagnosis criteria for early kidney disease in high-risk populations; 2) advance prevention and treatment of CKD in patients with type 1 or type 2 diabetes, or elderly patients, for whom no current accurate marker of kidney disease is available; and 3) estimate the public health burden and trends of CKD.
Last Updated: July 6, 2016
Food and Drug Administration (FDA)
The FDA and the American Society of Nephrology (ASN) co-founded the Kidney Health Initiative (KHI), a public-private partnership, in 2012. 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 FDA and the greater nephrology community can interact to optimize evaluation of drugs, devices, biologics, and food products. Details regarding mission and organizational structure of KHI may be found on the KHI website. Member organizations include patient organizations, professional organizations, regulated industry (including both pharmaceutical and device companies), dialysis providers, academic research organizations, contract research organizations, research institutes, and other government agencies. Voting activities of the Board of Directors includes the endorsement of projects proposed by the membership.
Criteria for project endorsement are:
- Adherence to KHI mission
- Impact potential
KHI projects rely on the participation and sweat equity of KHI members to produce the project deliverables, however membership is not a requirement for participation in KHI workgroups. Since its inception in 2012, the founding partners (FDA and ASN) conceived of the three pilot projects undertaken immediately by KHI. One project is designed to address the paucity of data that exist to guide the drug dosing of critically ill patients with acute kidney injury receiving continuous renal replacement therapies (CRRT). Another project is designed to elucidate appropriate endpoints for lupus nephritis trials. A final pilot project already underway is a white paper intended to identify barriers to innovation in the kidney health space. The intent is that the white paper may serve as a roadmap for future KHI projects that will be generated by the KHI members. While participation in KHI workgroups is not restricted to KHI members, KHI holds annual stakeholders meetings for its members where proposed projects ideas are discussed and developed. KHI members are also able to submit project proposals through the KHI website. The annual membership fees vary depending on the size and type of organization, ranging from $30,000/year to free.
Patrick Archdeacon, MD
Medical Officer, Center for Drug Evaluation and Research
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
The Chronic Renal Diseases Program supports basic and clinical research on renal development and disease, including: (1) causes, pathogenetic mechanisms, and pathophysiology; (2) morphological and functional markers and diagnostic measures, including biomarkers; (3) underlying mechanisms leading to progression of renal disease; (4) functional adaptation to progressive nephron loss; (5) natural history of progressive renal diseases; and (6) identification and testing of possible therapeutic interventions to prevent development or halt progression of renal disease. Research in this program includes the primary glomerulopathies and renal disease from systemic diseases that collectively account for more than 80 percent of all cases of treated end-stage renal disease.
Kevin Abbott, MD, MPH
Program Director, Division of Kidney, Urologic, and Hematologic Diseases
The Chronic Renal Insufficiency Cohort (CRIC) Study is an ongoing prospective observational cohort study of approximately 4,000 men and women with chronic kidney disease (CKD). The study population includes about one-half African Americans and one-half is composed of persons with diabetes; two subgroups at increased risk for kidney failure (end-stage renal disease-ESRD). The objective of this nationwide study is to identify factors associated with rapid decline in kidney function and factors associated with worsening of pre-existing or development of cardiovascular disease. Information from the study will be used to plan future clinical trials to slow the progression of CKD and to reduce associated morbidity, including cardiovascular disease. The first cohort of CRIC Study participants, which included persons with mild to moderate CKD, were enrolled from 2003 to 2008. They are followed each year with in-person clinic visits with an interim telephone call. In July 2013 recruitment began for a second cohort (1,500 participants) of study participants with more preserved kidney function. All study participants will be followed until 2018 and possibly longer. A number of ancillary studies have been conducted (and many are ongoing) which examined a broad range of outcomes and risk factors of CKD. New ancillary studies continue to be implemented.
The CKiD study examines CKD progression and its effects in children recruited between ages 1-16. It aims to determine risk factors for progression of pediatric CKD and to examine the impact of CKD on neurocognitive development, risk factors for cardiovascular disease, and growth. The current phase of the study is scheduled to end in 2018. A description of the baseline characteristics of the cohort has been published by in the Clinical Journal of the American Society of Nephrology. Another manuscript summarizing findings through 2012 is published in the American Journal of Kidney Disease. This study has had more than seventy publications to date.
Veterans Affairs (VA)
The VA is a major sponsor of scientific research in the United States; the VA research budget in 2013 was $581 million which supported a renal research portfolio of $19.1 million. The VA Cooperative Studies Program (CSP) is an arm of the VA research program that conducts multisite clinical trials examining issues important to Veteran health. For nearly two decades the VA CSP has been continuously conducting clinical trials in kidney related research, the results of which have been published in high impact journal such as the Journal of the American Medical Association (JAMA) and the New England Journal of Medicine (NEJM).
This information was reviewed by KICC agency representatives. It may not reflect new or future agency activities. For more information, please contact the listed representatives.