Scientific Research
This section describes basic and clinical research activities supported or sponsored by the Federal government.
Centers for Disease Control and Prevention (CDC)
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.
Contact Information
Gary Myers, PhD, FACB
Chief, CDC Clinical Chemistry Branch
Phone: 770–488–4606
Email: GMyers@cdc.gov
Web: www.cdc.gov/diabetes/projects/kidney.htm
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.
Contact Information
Meda Pavkov, MD, PhD
Phone: 770–488–1160
Email: MPavkov@cdc.gov
Website: www.nia.nih.gov/ResearchInformation/ScientificResources/HealthABCDescription.htm
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Food and Drug Administration (FDA)
The FDA Center for Drug Evaluation and Research (CDER) is planning to conduct research to assess the impact of different renal function estimating equations for 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 on the drug label. However, many clinical laboratories are now reporting estimates of renal function using the Modification of Diet in Renal Disease (MDRD) Study equation. Moreover, the movement to standardize the serum creatinine assay measurements has further raised the issue of validity of the renal function estimating equations developed, based on non-standardized assays for drug dosing. FDA will first explore whether or not the MDRD, an estimation of filtration, can adequately predict the level of drug exposure for drugs that are excreted by the kidney as compared with CG.
This and other chronic kidney disease research projects are funded under the Critical Path Initiative and Regulatory Science and Review Enhancement research grant.
Contact Information
Nancy Xu, MD
Medical Officer, Center for Drug Evaluation and Research
Phone: 301–796–4079
Email: nancy.xu@fda.hhs.gov
Web: www.fda.gov/cder
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.
Contact Information
Max Robinowitz, MD
Medical Officer, Center for Devices and Radiological Health
Phone: 240–276–1300
Email: max.robinowitz@fda.hhs.gov
Web: www.fda.gov/cdrh
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Health Resources and Services Administration (HRSA)
The Clinical Interventions to Increase Organ Procurement 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 of deceased donor organs (e.g. heart, liver, lung, pancreas, kidney, and intestine) in the United States.
HRSA has an Interagency Agreement with the NIH to provide additional funding for the NIH/National Institute of Allergy and Infectious Diseases’ Clinical Outcomes of Live Organ Donors Consortium. This consortium will plan and execute studies that address the outcomes of living kidney and lung donors.
The Organ Procurement and Transplantation Network (OPTN) collects and manages scientific data about organ donation and transplantation. Additionally, HRSA’s Scientific Registry of Transplant Recipients (SRTR), a national database of statistics related to solid organ transplantation, supports the development of sound policy, encourages research on issues of importance to the transplant community, and facilitates responsible analysis of transplant programs and organ procurement organizations.
Contact Information
Richard Durbin
Acting Director, Division of Transplantation
Phone: 301–443–6804
Email: RDurbin@hrsa.gov
Web: www.ask.hrsa.gov/Organ.cfm
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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.
Contact Information
Lawrence Agodoa, MD
Director, Office of Minority Health Research Coordination
Phone: (301) 594-1932
Email: agodoal@extra.niddk.nih.gov
Web: www2.niddk.nih.gov/Research/ScientificAreas/Kidney/BCKD.htm
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.
Contact Information
John Kusek, PhD
Senior Scientific Advisor, Division of Kidney, Urologic, and Hematologic Diseases
Phone: 301-594-7735
Email: kusekj@extra.niddk.nih.gov
Web: www.niddk.nih.gov/patient/cric/cric.htm
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 first phase of the study ended in 2008 and now will continue to follow the patient cohort is being followed for an additional five years.
Contact Information
Marva Moxey-Mims, MD
Director, Pediatric Nephrology & Renal Centers Programs
Phone: (301) 594-7717
Email: marva.moxey-mims@nih.hhs.gov
Web: www.statepi.jhsph.edu/ckid
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. |
