Cardiovascular and Renal Events in Kidney Disease

描述（由申请人提供）：本提案的目的是使Ojo博士能够投入50%的精力进行临床研究，并指导以患者为导向的研究学员。建议的指导计划主要使用的研究项目有：(1)慢性肾功能不全队列研究（CRIC）；(2)叶酸对移植血管预后降低的研究（FAVORIT）；(3)移植受者科学登记（SRTR）。CRIC是美国国立卫生研究院（nih）赞助的一项多中心前瞻性队列研究，旨在确定肾功能加速下降的危险因素，并评估慢性肾功能不全（CRI）患者心血管疾病（CVD）的发病率和危险因素。CRIC将为受指导的受训者提供非实验研究设计的实际应用。FAVORIT是美国国立卫生研究院（nih）赞助的一项多中心、随机、双盲对照临床试验，旨在确定在稳定肾移植受者中，用标准复合维生素加叶酸、维生素b12和维生素B6的高剂量联合治疗降低总同型半胱氨酸（tHcy），与不含这三种B族维生素的标准复合维生素治疗相比，是否能降低复发和新生心血管疾病的总发生率。FAVORIT将作为指导学员设计、实施和分析随机临床试验的模板。SRTR是一个纵向数据库，旨在对美国实体器官检索、分配和移植相关的以患者为中心的结果进行科学调查。SRTR将作为实习生进行假设驱动的临床流行病学结果研究的实习。指导计划：该奖项将要求开发和实施一个综合指导计划，从奖学金的第一年开始，由三个关键部分组成：(1)500例患者的观察性研究（CRIC）的实践经验，200例患者的随机治疗性临床试验（FAVORIT）和30万器官受体数据库（SRTR）的结果分析；(2)通过临床研究或流行病学硕士学位或灵活设计的课程，对以患者为导向的研究方法进行严格的教学指导；(3)通过密歇根大学研究责任计划，对人类受试者研究中的权利、伦理和责任进行持续培训。

DESCRIPTION (provided by applicant):The aim of this proposal is to enable Dr. Ojo to devote 50% effort to conduct clinical research and to mentor patient-oriented research trainees. The research projects that will be principally utilized for the proposed mentoring plan are: (1) The Chronic Renal Insufficiency Cohort Study (CRIC); (2) The Folic Acid for Vascular Outcome Reduction in Transplantation Study (FAVORIT); and (3) The Scientific Registry for Transplant Recipients (SRTR). CRIC is an NIH-sponsored, multicenter, prospective cohort study designed to determine the risk factors for accelerated decline in renal function and to evaluate the incidence and risk factors for cardiovascular disease (CVD) in patients with chronic renal insufficiency (CRI). The CRIC will provide the mentored trainees with hands-on application of a nonexperimental study design. The FAVORIT is an NIH-sponsored, multicenter, randomized, double-blind controlled clinical trial designed to determine whether total homocysteine (tHcy)-lowering treatment with a standard multivitamin augmented by a high dose combination of folic acid, vitamin B 12, and vitamin B6 versus treatment with a standard multivitamin devoid of these three B-vitamins, reduces the pooled rate of recurrent and de novo CVD outcomes in stable renal transplant recipients. The FAVORIT will be used as a template to instruct the trainees in the design, conduct and analysis of randomized clinical trials. The SRTR is a longitudinal database designed to conduct scientific investigations of patient-centered outcomes relevant to solid organ retrieval, allocation, and transplantation in the U.S. The SRTR will serve the trainee as a practicum for hypothesis-driven clinical epidemiologic outcome studies. Mentoring Plan: This award will entail the development and implementation of an integrated mentoring program starting from the first year of fellowship and consisting of three key components: (1) the practical experience of an observational study of 500 patients (CRIC), a randomized therapeutic clinical trial of 200 patients (FAVORIT) and outcomes analyses with a database of 300,000 organ recipients (SRTR); (2) rigorous didactic instructions in patient-oriented research methodologies through a Master degree in Clinical Research or Epidemiology program or flexibly designed set of course work; and (3) continuous training on rights, ethics and responsibilities in research with human subjects through the University of Michigan Research Responsibility Program.