OHIO STATE UNIVERSITY APPLICATION TO AASK

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The African-American Study of Kidney Disease and Hypertension (AASK) is a multicenter, prospective, double-masked, randomized study which will determine the extent to which control of blood pressure, using 3 different antihypertensive regimens, can control the progression of hypertensive nephrosclerosis in African-Americans. The study is currently in Phase II. The Ohio State University seeks to be one of the 14 centers to be involved in the full-scale study (Phase III). We suggest that the Ohio State University program is well qualified to participate in Phase III of the AASK by virtue of: 1. Our experience in the conduct of controlled clinical trials involving blood pressure control and/or renal disease. These include: NIH Modification of Diet in Renal Disease (MDRD) Study; NIH/Bristol-Squibb Study of Captopril Therapy in Type I Diabetes and Nephropathy; NIH Trial of Plasmapheresis in Severe Lupus Nephritis; NIH Study of the Adult Nephrotic Syndrome; NIH/Hoechst Study of Ramipril therapy in Type I Diabetes and Nephropathy (active); NKF of Canada/Sandoz North American Nephrotic Syndrome Study (active); Sandoz MIST Study of Salt Sensitivity and Calcium Channel Blocker Therapy in Essential Hypertension (active); ADA Study of Insulin Sensitivity and Blood Pressure in Black Patents (active). 2. Our documented ability to recruit African-Americans and women into these clinical trials in proportion to their numbers in Central Ohio and the disease entity. 3. The favorable demographics of Columbus, Ohio, "urbanized area', including a population of approximately 1.4 million, 12% of whom are African-American (165,000). 4. The well-developed Nephrology clinical research space including an experienced GFR laboratory which performs approximately 500 GFRs/year for both clinical and research purposes. 5. Our ongoing studies specifically addressing the problem of hypertension and renal disease in African-Americans. 6. The presence of ongoing programs that will directly aid in recruitment and retention of patients for the AASK. Those programs include: our affiliation with the State of Ohio "Ohio Risk Reduction Program (ORRP)", which is in the process of screening 1,200 adult urban African-Americans for health risk factors such as hypertension. Blood studies will identify those with increased serum creatinine levels for evaluation for the AASK; our Continuing Medical Education (CME) programs on hypertension and the kidney for Central Ohio physicians; support of the AASK by prominent members of the Central Ohio African-American community. 7. Our preparedness to begin recruitment to the AASK. We have already identified 17 patients from our programs who are candidates for the AASK. Thus, we are prepared to begin recruitment immediately.