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: 8323101
• 负责人: HAROLD I FELDMAN
• 金额: $ 249.44万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-28 至 2013-09-04
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8323101
• 关键词: Address; Adult; Adverse event; Advisory Committees; Affect; American; Ancillary Study; Area; 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的临床流行病学与生物统计学中心（CCEB）的申请，继续担任慢性肾脏不足症同胞（CRIC）研究的科学和数据协调中心（SDCC）。慢性肾功能不全（CRI）影响超过1000万美国人。它们的发病率负担源于其频繁发展为末期肾脏疾病（ESRD）和心血管事件的不成比例风险。一组共有的病因因素被确定为可能导致进行性肾脏疾病和心血管疾病（CVD）（包括临床和生物标志物）的原因。表征这些危险因素和结果之间的关系将允许开发工具，以预测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。在2001 - 2007年之间，前瞻性慢性肾功能不全队列（CRIC）的研究纳入了> 3600名患有慢性肾脏疾病的成年人，以解决鉴定肾脏疾病快速进展的预测因素，并阐明肾脏功能障碍的关系，并在2001年成年人，以确定肾脏功能障碍的肾脏功能障碍和肾脏功能障碍和临床性心血管疾病的风险，死亡，死亡和资源的风险。在宾夕法尼亚州的调查人员的领导下，受试者的招聘和保留率超出了目标，数据的质量也很出色。此外，CRIC辅助研究计划在通过23项资助的联邦奖项通过CRIC的科学范围方面非常成功。拟议的CRIC阶段将延长到2013年的后续行动，为CRIC提供了一个独特的机会，以利用CRIC的现有努力和成功，以建立慢性肾脏疾病的参与者，这些参与者对肾脏疾病进展以及包括后末期肾脏疾病健康状况在内的各种结果进行了长期前瞻性随访。这种无与伦比的资源将扩大与慢性肾脏疾病自然史有关的科学，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的包括：1）设置和促进慢性肾脏病研究议程，2）领导CRIC II期的各个方面的行为，3）开发过程以促进CKD中的随机，对照试验，以及4）4）与其他临床研究相互作用，以促进促进协作CRI研究。