The research program outlined in this application is designed to provide a mechanism for randomizing 50-60 patients with progressive renal insufficiency to various dietary protocols. The proposed program will be conducted in the Ambulatory Clinical Research Unit of the Nephrology Section of the Department of Medicine of the Bowman Gray School of Medicine, in Winston-Salem, North Carolina. Patients will be recruited from three clinics: the BGSM private nephrology clinic, a private nephrologist who practices in the community in Winston-Salem, and the Danville Urology Clinic (DUC), a nephrology unit located in Danville, Virginia. Nephrologists at both these latter institutions have clinical faculty appointments at the Bowman Gray School of Medicine. A detailed study of patients in the BGSM clinic has identified 1281 active patients, 470 of whom have renal failure. Sixty-five patients with renal meet all criteria of the MDRD protocol. It is estimated that approximately half of this group of 65 could be recruited into the study, representing a yield of 2.0-2.5% of active patients. Applying somewhat lower yields to the other Winston-Salem clinic and the DUC, we estimate that a total of approximately 58-67 patients can be recruited into the MDRD study. Contingency plans for recruiting patients from four other clinics in the Winston-Salem area are also outlined. The study has four investigators. Three are nephrologists with extensive experience in the care of patients with renal failure. The fourth investigator is an epidemiologist expert in clinical trials and patient compliance. All are on the full-time faculty of the Bowman Gray School of Medicine. The senior dietitian has experience in clinical trials involving dietary intervention. Other key personnel have experience in clinical trials and in techniques needed for assuring patient compliance.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK039366-06
Application #
3550830
Study Section
Diabetes, Endocrinology and Metabolic Diseases B Subcommittee (DDK)
Project Start
1988-09-30
Project End
1993-11-30
Budget Start
1993-03-15
Budget End
1993-11-30
Support Year
6
Fiscal Year
1993
Total Cost
Indirect Cost
Name
Wake Forest University Health Sciences
Department
Type
Schools of Medicine
DUNS #
041418799
City
Winston-Salem
State
NC
Country
United States
Zip Code
27106