This section describes basic and clinical research activities supported or sponsored by the Federal government.
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 intramural research on the burden of CKD in the general and in special populations (e.g., mortality among people with CKD and incidence of kidney failure among people with diabetes, among other topics).
CDC is working to determine the loss of albumin due to adsorption on the walls of urine collection containers and the sample cups used on analytical instrumentation. Different container materials from different vendors and various surface conditions are evaluated using urine spiked with albumin. CDC is evaluating and comparing biological variability of urine albumin in 24-hour urine collections, timed overnight collections, and first and second morning collections in the general U.S. population. Persons representing different race/ethnicity groups with increased urinary albumin excretion will be identified and sampled. CDC will also determine the impact of multiple freeze and thaw cycles on urinary albumin concentration.
Sharon Saydah, PhD
CDC Division of Diabetes Translation
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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 (http://www.asn-online.org/khi/ ). 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 1) adherence to KHI mission, 2) impact potential, and 3) feasibility. 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. Membership details may be found at http://www.asn-online.org/khi/ .
Patrick Archdeacon, MD
Medical Officer, Center for Drug Evaluation and Research
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Health Resources and Services Administration (HRSA)
The Clinical Interventions to Increase Organ Procurement Grant Program (funded for FY 2002-2013) provides support for the implementation and evaluation of highly promising strategies and approaches that can serve as model interventions for identifying appropriate donation candidates, evaluating donated organs (including kidneys), maintaining donor stability, and optimizing methods for organ procurement. The ultimate goal of this grant program is to increase the number and quality of deceased donor organs (e.g. heart, liver, lung, pancreas, kidney, and intestine) in the United States.
Summaries of grants previously funded through this program are available at http://organdonor.gov/dtcp/clinical.html .
Director, Division of Transplantation
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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; (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.
Lawrence Agodoa, MD
Director, Office of Minority Health Research Coordination
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.
John Kusek, PhD
Senior Scientific Advisor, Division of Kidney, Urologic, and Hematologic Diseases
The CKiD study examines CKD progression and its effects in children 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 three dozen publications to date.
Marva Moxey-Mims, MD
Director, Pediatric Nephrology & Renal Centers Programs
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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).
VHA National Kidney Program
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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.