Continuation of the Chronic Renal Insufficiency Cohort (CRIC) Study

慢性肾功能不全队列 (CRIC) 研究的继续

• 批准号: 7903050
• 负责人: HAROLD I FELDMAN
• 金额: $ 69.62万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-25 至 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7903050
• 关键词: Address; Adult; Adverse event; Advisory Committees; Affect; American; Ancillary Study; Area; Arts; Award; Biochemical; Biochemistry; Biological Markers; Biometry; Cardiology; Cardiovascular Diseases; Cardiovascular system; Categories; Cessation of life; Characteristics; Chronic Kidney Failure; Chronic Kidney Insufficiency; Clinical; Clinical Research; Cohort Studies; Communication; Complement; Confidentiality; Data; Data Analyses; Data Collection; Data Coordinating Center; Data Quality; Development; Device or Instrument Development; Diagnostic Imaging; Disease; Echocardiography; Electrocardiogram; Electron Beam; End stage renal failure; Enrollment; Ensure; Epidemic; Epidemiology; Evaluation; Event; Film; Functional disorder; Funding; Genotype; Goals; Health; Health Status; Internet; Intervention; Investigation; Kidney; Kidney Diseases; Kidney Failure; Knowledge; Laboratories; Lead; Leadership; Logistics; Manuscripts; Measures; Medical center; Modeling; Monitor; Morbidity - disease rate; National Institute of Diabetes and Digestive and Kidney Diseases; Nephrology; Online Systems; Outcome; Participant; Patients; Pennsylvania; Phase; Physiological; Preventive; Procedures; Process; Protocols documentation; Randomized Controlled Trials; Reading; Reporting; Research; Research Activity; Research Personnel; Resources; Risk; Risk Factors; Science; Scientist; Security; Site; Specimen; Subgroup; System; Techniques; Testing; Ultrasonography; United States National Institutes of Health; Universities; X-Ray Computed Tomography; abstracting; base; cardiovascular risk factor; clinical epidemiology; cohort; data management; design; disease natural history; distributed data; experience; follow-up; high risk; improved; meetings; member; programs; prospective; quality assurance; repository; sample collection; success; treatment trial

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.

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学中心 (CCEB) 的一份申请，旨在继续担任慢性肾功能不全队列 (CRIC) 研究的科学和数据协调中心 (SDCC)。 Chronic renal insufficiency (CRI) affects over 10 million Americans.他们的发病负担来自于他们频繁进展为终末期肾病（ESRD）以及心血管事件的不成比例的风险。一组共同的病因学因素被确定为可能导致进行性肾病和心血管疾病（CVD）的因素，包括临床和生物标志物。描述这些风险因素和结果之间的关系将有助于开发工具来预测 CRI 患者的不良结果，并增强对导致这些结果的病因机制的理解。 2001 年至 2007 年间，前瞻性慢性肾功能不全队列 (CRIC) 研究招募了超过 3600 名患有慢性肾脏疾病的成年人，以实现确定肾脏疾病快速进展的预测因子的总体目标，并通过最初的 5 年随访阐明肾功能障碍与亚临床和临床心血管事件、死亡和资源利用风险之间的关系。在宾夕法尼亚大学研究人员的领导下，受试者招募和保留已经超出了目标，并且数据质量非常出色。此外，CRIC 辅助研究计划通过 23 项资助的联邦奖项，在扩大 CRIC 的科学范围方面取得了巨大成功。拟议的 CRIC 第 2 阶段将随访期延长至 2013 年，提供了一个独特的机会，利用 CRIC 现有的努力和成功，建立一个慢性肾病参与者队列，对肾病进展和包括终末期肾病健康状况在内的各种结果进行长期前瞻性随访。这种无与伦比的资源将扩大与慢性肾脏疾病自然史以及对心血管疾病和其他不良事件的影响相关的科学。 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病研究议程，2) 领导 CRIC 第二阶段所有方面的开展，3) 制定流程以促进 CKD 随机对照试验，4) 促进与其他临床研究的互动，以促进协作 CRI 研究。