Continuation of the Chronic Renal Insufficiency Cohort (CRIC)

项目摘要 本申请由密歇根大学临床流行病学和生物统计学中心提交。 宾夕法尼亚州将担任慢性病第5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年启动以来，审评委的研究已经招募和 对一个由5,625名在7岁时肾功能减退的不同种族和民族组成的队列进行了随访。 在美国各地的中心。作为CKD的里程碑式前瞻性评价，CRIC研究 进行了广泛而深入的生物学、生理学和社会表型分析，并确定了纵向 多个领域的临床和以患者为中心的结局。审评委研究的结果界定了 CKD进展的轨迹，记录CKD合并症的发展和演变，并确定 多种因素和途径解释成人CKD的进展和并发症。 通过其富有成效的辅助研究和机会池计划， CRIC研究和肾脏疾病研究人员社区已显着扩大。期间 在最近的资助周期（第4阶段：2018-2023年），实施了三项创新子方案研究， 通过对肾功能和心血管疾病的高度精细的家庭评估来丰富CRIC数据 措施在审评委研究的第五阶段即最后阶段，主要目标是：（1）确定 所有参与者的临床结局，包括入组4期子方案的参与者，（2）进行分析 将子协议测量与临床结果联系起来，（3）整合来自多个领域的数据，以识别 CKD进展结局异质性的潜在亚表型，（4）进行最终研究访视， （5）通过与以下机构的联系，建立今后数据收集的机制： 外部卫生数据来源，以及（6）生成工具和资源，以便利审评委数据的持续使用 在审评委的研究正式结束后，由一个广泛的调查小组对生物标本进行评估。一个重要 第5阶段分析活动的产品将是一个数据驱动的整体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，告知患者护理， 并指导未来临床试验的设计。SDCC由经验丰富的调查人员团队领导， 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，将产生新的科学产出，并成功地 将审评委的研究从积极的前瞻性队列研究阶段过渡到长期的资源， 正在进行的和未来的机制，流行病学和转化研究。

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.