This section describes basic and clinical research activities supported or sponsored by the Federal government.
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. Containers from different vendors, different container materials, and various surface conditions will be evaluated using urine spiked with albumin. CDC will evaluate biological variability of urine albumin observed in a 24-hour urine collection, a timed overnight collection, and first and second morning collections. The findings from this work will be validated by measuring real patient samples to determine urinary albumin loss under optimal collection conditions. Patients representing different ethnicities with increased urinary protein will be identified and sampled. CDC will also try to determine the impact on albumin testing following multiple freeze/thaw cycles.
CDC's Supplement Health, Aging, and Body Composition Study characterizes the extent of change in body composition in older men and women and identifies clinical conditions accelerating these changes. Additionally, it examines the health impact of these changes on strength, endurance, disability, and weight-related diseases of old age. The study targets people aged 70 years or older at high risk of developing chronic kidney disease.
1) Optimizing Renal Dose Adjustments in Patients with Chronic Kidney Disease: The FDA Center for Drug Evaluation and Research (CDER) is conducting research to assess the impact of different renal function estimating equations on drug-dosing, and to address the question of whether or not Cockcroft-Gault (CG)-based dosing adjustments in current labels should be retained or replaced. Dose adjustments for renally-cleared drugs are frequently based on CG estimates of renal function in drug labels. However, many clinical laboratories are now reporting estimates of renal function using the Modification of Diet in Renal Disease (MDRD) equation. Moreover, the standardization of the serum creatinine assay has raised concern about the continued use of CG for drug dosing, as the equation was developed using non-standardized creatinine measurements. This project compares the ability of the CG and newer equations to predict drug exposure and drug-related safety and efficacy outcomes with additional focus on drugs that are predominately eliminated by the kidney and have narrow therapeutic index.
This research project is funded by Critical Path Initiative research grant.
2) Development of Patient Reported Outcomes in CKD:
Qualified patient reported outcomes that represent well-defined, reliable instruments can be used to establish the efficacy of a therapy. A recent joint workshop between the National Kidney Foundation (NKF) and FDA focused on the development of patient reported outcome measures for polycystic kidney disease, anemia of chronic kidney disease, and the nephrotic syndrome. Participants came from industry, academia, the Critical Path Institute, the NKF, the NIH and FDA. Discussions and work in this area are ongoing.
3) Standardization of Data Elements for Clinical Trials in Polycystic Kidney Disease:
The FDA has joined efforts with the Polycystic Kidney Disease (PKD) Foundation and the Clinical Data Interchange Standards Consortium (C-DISC) to standardize data elements for clinical trials in PKD. One goal of the PKD Outcomes Consortium Project is to aggregate data from registries and clinical trials in PKD. Another objective is to explore kidney size and rate of size increase as potential surrogate endpoints for drug approval by determining their relationship with other important clinical manifestations of PKD (e.g., hypertension, pain, renal function and quality of life measures). PKD specific data elements are placed on the CDISC website for public review on a rolling basis.
Shona Pendse, M.D., M.M.Sc
Medical Officer, Center for Drug Evaluation and Research
4) FDA pre- and post-marketing regulation of medical products intended for diagnosis and monitoring of renal disease.
The FDA Center for Devices and Radiologic Health (CDRH) carries out the pre-market and post-market regulation of medical devices for the diagnosis and monitoring of renal disease. These devices include diagnostic devices (e.g. radiologic and other imaging devices; in vitro diagnostic tests; and sensing devices including telemonitoring devices); therapeutic devices (e.g. dialysis, surgical, and nutritional devices); and general hospital devices (e.g. sterilization equipment and bandages).
CDRH also oversees the regulation of combination products such as in vitro diagnostic tests that are intended to select or exclude patients for treatment with a particular drug; therapeutic medical devices that contain a drug that is passively and actively released by the medical device; and imaging materials such as radiocontrast media where the material is regulated as a drug to be used with an imaging medical device.
Max Robinowitz, MD
Medical Officer, Center for Devices and Radiological Health
The Clinical Interventions to Increase Organ Procurement Grant Program 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, 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.
HRSA participates in and provides funding to NIH conducted studies including the National Institute of Allergy and Infectious Diseases' Clinical Outcomes of Live Organ Donors Consortium. This consortium studies the outcomes of living kidney and lung donors.
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
Phone: (301) 594-1932
The Chronic Renal Insufficiency Cohort (CRIC) Study is a prospective observational cohort study of nearly 4,000 men and women with mild to moderate 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 CKD. 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. The study will also develop predictive models to identify high-risk subgroups and identify etiological factors for future trials to reduce the burden of CKD and its associated morbidity. Participants will be followed for up to 10 years. A number of ancillary studies will examine genetic, behavioral, nutritional, associated morbidity (e.g., eye disease) and other factors for CKD.
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 2013. The manuscript describing the baseline characteristics of the cohort has been accepted for publication by the Clinical Journal of the American Society of Nephrology.
The VA is a major sponsor of scientific research in the US; the VA research budget in 2010 was $580 million. The VA Cooperative Studies Program (CSP) is an arm of the VA research program that conducts multisite clinical trials examining issues important to the 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). VA CSP recently collaborated with the National Institutes of Health (NIH) to perform the largest national trial of renal support in acute kidney injury, the results of which were reported in NEJM in 2008. Analysis of secondary endpoints and ongoing sub-studies are focusing on the impact of acute kidney injury on long term kidney function.
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.
Page last updated: March 1, 2012