Continuation of the Chronic Renal Insufficiency Cohort (CRIC) Study

描述(由申请人提供)： 这是宾夕法尼亚大学医学中心临床流行病学和生物统计中心(CCEB)继续作为慢性肾功能不全队列(CRIC)研究的科学和数据协调中心(SDCC)的申请。慢性肾功能不全(CRI)影响着1000多万美国人。他们的发病率负担源于他们频繁进展为终末期肾病(ESRD)和不成比例的心血管事件风险。一组共同的病因被确定为进行性肾脏疾病和心血管疾病(CVD)的潜在责任，包括临床和生物标记物。确定这些危险因素和预后之间的关系将有助于开发预测CRI患者不良预后的工具，并加强对导致这些预后的病因机制的理解。在2001-2007年间，前瞻性慢性肾功能不全队列(CRIC)研究招募了3600名患有慢性肾脏疾病的成年人，以解决首要目标，即确定肾脏疾病快速进展的预测因素，并通过最初5年的随访澄清肾功能障碍与亚临床和临床心血管事件、死亡和资源利用之间的关系。在宾夕法尼亚大学调查人员的领导下，受试者的招募和保留超过了目标，数据质量也很出色。此外，审评委的辅助研究方案非常成功地通过23项由联邦资助的奖项扩大了审评委的科学范围。拟议的审评委第二阶段将后续行动延长至2013年，提供了一个独特的机会，可以利用审评委现有的努力和成功，建立一批慢性肾脏疾病参与者，他们对肾脏疾病的进展和各种结果，包括终末期肾脏疾病的健康状况进行长期前瞻性跟踪。这一无与伦比的资源将扩大与慢性肾脏疾病自然史相关的科学，以及对心血管疾病和其他不良事件的影响。CRICSDCC在第二阶段的总体具体目标包括：1)制定和促进慢性肾脏疾病研究议程，2)领导CRIC第二阶段的所有方面的实施，3)开发流程以促进慢性肾脏病的随机对照试验，以及4)促进与其他临床研究的互动，以促进合作的CRI研究。

DESCRIPTION (provided by applicant): This is an application from the Center for Clinical Epidemiology and Biostatistics (CCEB) at the University of Pennsylvania Medical Center to continue serving as the Scientific and Data Coordinating Center (SDCC) for the Chronic Renal Insufficiency Cohort (CRIC) Study. Chronic renal insufficiency (CRI) affects over 10 million Americans. Their burden of morbidity derives from their frequent progression to end-stage renal disease (ESRD) and disproportionate risk of cardiovascular events. A shared set of etiological factors is being identified as potentially responsible for both progressive renal disease and cardiovascular disease (CVD) including clinical and biomarkers. Characterizing relationships between these risk factors and outcomes will permit development of instruments to predict poor outcomes in patients with CRI and enhance understanding of etiological mechanisms leading to these outcomes. Between 2001-2007, the Prospective Chronic Renal Insufficiency Cohort (CRIC) Study enrolled >3600 adults with chronic kidney disease to address overarching goals of identifying predictors of rapid progression of kidney disease and clarifying the relationship between kidney dysfunction and the risks of subclinical and clinical cardiovascular events, death, and resource utilization through an initial 5-year follow-up. Under the leadership of investigators at Penn, subject recruitment and retention have exceeded goals and the quality of data has been outstanding. In addition, the CRIC Ancillary Studies Program has been remarkably successful in expanding the scientific scope of CRIC through 23 funded federal awards. The proposed Phase 2 of CRIC, which extends follow-up through 2013, offers a unique opportunity to leverage the existing effort and success of CRIC to establish a cohort of participants with chronic kidney disease who have long-term prospective follow-up on progression of kidney disease and a variety of outcomes including post-end-stage renal disease health status. This unparalleled resource will expand the science related to chronic kidney disease natural history as well as the impact on cardiovascular disease and other adverse events. The overarching specific aims of the CRICSDCC in Phase II include: 1) set and promote a Chronic Kidney Disease Research Agenda, 2) lead the conduct of all aspects of CRIC Phase II, 3) develop processes to promote randomized, controlled trials in CKD, and 4) facilitate interactions with other clinical studies to promote collaborative CRI research.