OHIO STATE UNIVERSITY APPLICATION TO AASK

非裔美国人肾脏疾病和高血压研究(AASK)是 一项多中心、前瞻性、双盲、随机研究，将 确定血压控制的程度，使用3 不同的降压方案，可以控制病情的进展 非裔美国人中的高血压肾病。这项研究是 目前处于第二阶段。俄亥俄州立大学寻求成为 14个中心将参与全面研究(第三阶段)。我们 表明俄亥俄州立大学的项目完全有资格 通过以下方式参与AASK的第三阶段： 1.我们在进行对照临床试验方面的经验 血压控制和/或肾脏疾病。其中包括：美国国立卫生研究院 肾脏疾病饮食调整(MDRD)研究；NIH/百时美施贵宝 卡托普利治疗I型糖尿病和肾病的研究；NIH试验 血浆置换治疗重症狼疮性肾炎；美国国立卫生研究院成人研究 肾病综合征；NIH/Hoechst关于雷米普利治疗I型的研究 糖尿病和肾病(活动性)；加拿大NKF/Sandoz北美 肾病综合征研究(活动)；Sandoz Mist盐敏感性研究 和钙通道阻滞剂治疗高血压(主动)； 黑人患者胰岛素敏感性和血压的ADA研究 (活动)。 2.我们有记录的能力招募非裔美国人和妇女加入 这些临床试验与他们在俄亥俄州中部和 疾病实体。 3.俄亥俄州哥伦布市的有利人口统计数据：“城市化地区”， 包括大约140万人口，其中12%是 非洲裔美国人(165,000人)。 4.发展良好的肾病临床研究空间，包括 经验丰富的GFR实验室，每年提供约500个GFRS 临床和研究两方面的目的。 5.我们正在进行的研究特别针对以下问题 非裔美国人中的高血压和肾脏疾病。 6.正在进行的计划的存在将直接帮助 为AASK招募和留住患者。那些节目 包括：我们与俄亥俄州的关系“俄亥俄州风险降低” 该计划(ORRP)正在对1,200名城市成年人进行筛查 非裔美国人的健康风险因素，如高血压。血样 研究将确定那些血清肌酐水平升高的人 评估AASK；我们的继续医学教育(CME)计划 为俄亥俄州中部医生提供高血压和肾脏方面的支持 俄亥俄州中部非洲裔美国人杰出成员的AASK 社区。 7.我们准备开始招募AASK成员。我们已经这么做了 从我们的项目中确定了17名患者，他们是AASK的候选人。 因此，我们准备立即开始招聘。

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.