Continuation of the Chronic Renal Insufficiency Cohort (CRIC)

项目总结 本申请由加州大学临床流行病学和生物统计中心提交 宾夕法尼亚州将作为慢性病第五阶段的科学和数据协调中心(SDCC) 肾功能不全队列(CRIC)研究。自2001年成立以来，审评委的研究已经招募和 遵循了一组种族和民族多样化的5,625名肾功能减退患者的研究结果 中心遍布全美。作为对CKD的里程碑式的前瞻性评估，CRIC研究 进行了广泛而深入的生物、生理和社会表型鉴定，并确定了纵向 多个领域的临床和以患者为中心的结果。CRIC研究的发现定义了 慢性肾脏病进展轨迹，慢性肾脏病共病的发展和演变的编目，并确定 解释成人慢性肾脏病进展和并发症的各种因素和途径。 通过其卓有成效的辅助研究和机会池计划， CRIC的研究和肾脏疾病研究人员的社区已经明显扩大。在.期间 在最近一个供资周期(第四阶段：2018-2023年)，实施了三项创新性的次级议定书研究，以 通过基于家庭的高度精细的肾功能和心血管评估丰富CRIC数据 措施。在审评委研究的第五阶段和最后阶段，主要目标将是：(1)确定 所有参与者的临床结果，包括那些登记在阶段4子方案中的人，(2)执行分析 将子方案测量与临床结果联系起来，(3)整合来自多个领域的数据以确定 CKD进展结果异质性的亚表型，(4)进行最终研究访问 有资格进入第5阶段的审评委全部队列，(5)通过与以下方面的联系为今后的数据收集建立机制 卫生数据的外部来源，以及(6)生成工具和资源，以促进审评委数据的持续使用 在CRIC研究正式结束后，由一大批调查人员对生物检疫和生物检疫进行调查。一个重要的 阶段5分析活动的产品将是数据驱动的整体CKD框架，该框架将描述 CKD进展和心血管并发症的复杂相互作用，为患者护理提供信息， 并指导未来临床试验的设计。SDCC由一支经验丰富的调查团队领导，来自 宾夕法尼亚大学、杜兰大学和西北大学将提供科学和 业务领导，以确保审评委研究组实现这些目标。拟议的活动， 临床中心和SDCC之间的协调，将产生新的科学成果并成功 将审评委的研究从积极的、预期的队列阶段转变为长期的支持资源 正在进行的和未来的机械性、流行病学和转化性调查。

PROJECT SUMMARY This application is submitted by the Center for Clinical Epidemiology and Biostatistics at the University of Pennsylvania to serve as the Scientific and Data Coordinating Center (SDCC) for Phase 5 of the Chronic Renal Insufficiency Cohort (CRIC) Study. Since its inception in 2001, the CRIC Study has enrolled and followed a racially and ethnically diverse cohort of 5,625 individuals with reduced kidney function at 7 Clinical Centers across the United States. As the landmark prospective evaluation of CKD, the CRIC Study has performed extensive and deep biological, physiological, and social phenotyping, and ascertained longitudinal clinical and patient-centered outcomes across multiple domains. Findings from the CRIC Study have defined trajectories of CKD progression, catalogued development and evolution of comorbidities in CKD, and identified a diverse array of factors and pathways that explain the progression and complications of CKD in adults. Through its highly productive Ancillary Studies and Opportunity Pool Programs, both the scientific scope of the CRIC Study and the community of kidney disease researchers have been markedly expanded. During the most recent funding cycle (Phase 4: 2018-2023), three innovative subprotocol studies were implemented to enrich CRIC data with highly granular home-based assessments of kidney function and cardiovascular measures. During the fifth and final phase of the CRIC Study, the major goals will be to (1) ascertain the clinical outcomes for all participants including those enrolled in the Phase 4 subprotocols, (2) perform analyses linking the subprotocol measurements to clinical outcomes, (3) integrate data from multiple domains to identify subphenotypes underlying the heterogeneity in CKD progression outcomes, (4) conduct final study visits for the full CRIC cohort eligible for Phase 5, (5) create mechanisms for future data collection via linkages with external sources of health data, and (6) generate tools and resources to facilitate ongoing use of CRIC data and biospecimens by a broad group of investigators after the CRIC Study has formally ended. An important product of the Phase 5 analytical activities will be a data-driven holistic CKD framework that will depict the complex interplay of contributors to CKD progression and cardiovascular complications, inform patient care, and guide the design of future clinical trials. The SDCC, led by a highly experienced team of investigators from the University of Pennsylvania, Tulane University, and Northwestern University, will provide scientific and operational leadership to ensure that the CRIC Study Group achieves these goals. The proposed activities, coordinated between the Clinical Centers and the SDCC, will generate new scientific output and successfully transition the CRIC Study from its active, prospective cohort phase to a long-lasting resource for supporting ongoing and future mechanistic, epidemiologic, and translational investigations.