MODIFICATION OF DIET IN RENAL DISEASE STUDY

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This application is to participate in the Cooperative Clinical Study of Dietary Modification on the Course of Progressive Renal Disease (MDRD Study). The MDRD is a multicenter collaborative clinical trial designed to ascertain whether or no dietary protein restriction may influence the rate of progression of chronic renal disease irrespective of the nature of the primary underlying process. George Washington University Medical School and Georgetown University School of Medicine both located in Washington, District of Columbia have decided to participate in the study as one center. The Objectives of the Research Plan are to demonstrate: 1) That the Renal Divisions of these Universities have the interest, experience, facilities and patient resources necessary to participate in this study. The interest is due to the unique characteristics of the Greater Metropolitan Washington Area in terms of the prevalence (1,437.6 per 106 compared to 405.2 per 106 in the est of the country) and incidence (375.3 per 106 compared to 143.1 per 106 in the rest of the country) of chronic renal disease. By participating in the study as a consortium GWU- GU will pool their resources and avoid institutional competition. The experience of the P.I and Co P.I. will allow for cooperation and successful completion of the study. The facilities of both Renal Divisions are more than adequate for the study. Office space will be exclusively dedicated for the study. Patient resources. Both Divisions are clinically oriented with large patient population and facilities for clinical research. 1) The Planned Recruitment Campaign includes extensive use of Local Government offices, the study will be supported by the Commissioner of Public Health with at least 17 peripheral outpatient facilities, and religious leaders of the community. Radio, Television and Newspaper campaigns will be started. III) Potential Sources of Patients: At GWU: Include, the local HMO, the Division of Internal Medicine, Outpatient Health Clinics of the District of Columbia, private physicians. At GU: Include the outpatient clinical of the Renal Division and private physicians. IV) Estimated Patient pools: We estimate that at GWU we already have 20 patients from our own files for Group A. In Group B we have 10 patients from our files. At GU we have 10 patients for Group A and 20 patients in Group B. Therefore it will require a total recruitment of 5- 10 patients in the 21 months recruitment period.