Chronic Renal Insufficiency Cohort Limited competition continuation

项目总结 凯斯西储大学(CWRU)建议继续作为第五期的临床中心 慢性肾功能不全队列研究。慢性肾脏疾病(CKD)影响3700多万人 有可能发展为终末期肾病和心血管疾病的美国人 疾病和其他与残疾、护理费用高和过早死亡有关的合并症。因为它的 自2001年开始，审评委的研究招募并跟踪了5625名不同种族和民族的队列 来自美国7个临床中心的13个招募地点的肾功能减退的参与者。这个 CRIC的最初目标是建立一个临床研究实验室，旨在(A)确定新的预测因素 CKD进展，以及(B)表征心血管疾病的表现并确定其危险因素 在慢性肾脏病患者中。作为慢性肾脏病具有里程碑意义的前瞻性队列研究，CRIC研究已经 完成了广泛的生物、生理和社会表型分析，纵向随访，以及 确定多个领域的临床和以患者为中心的结果。审评委的调查结果 研究定义了慢性肾脏病进展的轨迹，编目了并存疾病的发展和演变 CKD，并确定了一系列不同的因素和途径来解释CKD的进展和并发症 成人慢性肾脏病。通过其高效的辅助研究和机会池计划， CRIC研究的科学范围和肾脏疾病研究人员的社区已经明显 扩大了。在最近一个供资周期(第四阶段：2018-2023年)，三项创新性的次级议定书研究 通过基于家庭的高度精细的肾功能评估丰富CRIC数据，并 心血管测量。在审评委研究的第五阶段和最后阶段，主要重点将是(1) 确定所有参与者的临床结果，包括那些登记参加第四阶段子方案的人，(2) 执行将子方案测量与临床结果联系起来的分析，(3)集成来自 确定CKD进展结果异质性潜在亚表型的域，(4)进行 对符合第5阶段资格的审评委全队列进行最终考察访问，(5)为今后的数据收集建立机制 通过与外部健康数据来源的联系，以及(6)生成工具和资源，以促进持续使用 在审评委的研究正式结束后，一大批调查人员对审评委的数据和生物谱进行了分析。 CWRU调查人员将与科学和数据协调中心及其他审评委密切合作 调查人员将产生新的科学成果，并成功地将审评委的研究从活跃的 预期队列阶段为支持当前和未来机制的长期资源， 流行病学和转化性调查。

PROJECT SUMMARY Case Western Reserve University (CWRU) proposes to continue to serve as a clinical center for Phase 5 of the Chronic Renal Insufficiency Cohort (CRIC) Study. Chronic kidney disease (CKD) affects over 37 million Americans who are at risk of progression to end stage kidney disease and development of cardiovascular disease and other comorbidities associated with disability, high costs of care and premature mortality. Since its inception in 2001, the CRIC Study has recruited and followed a racially and ethnically diverse cohort of 5,625 participants with reduced kidney function from 13 recruitment sites at 7 Clinical Centers across the US. The original aim of CRIC was to establish a clinical research laboratory designed to (a) identify novel predictors of CKD progression, and (b) characterize the manifestations of cardiovascular disease and identify its risk factors among individuals with CKD. As the landmark prospective cohort study of CKD, the CRIC Study has accomplished extensive biological, physiological, and social phenotyping, longitudinal follow-up, and ascertainment of 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 sub-protocol 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 focus will be to (1) ascertain the clinical outcomes for all participants including those enrolled in the Phase 4 sub-protocols, (2) perform analyses linking the sub-protocol measurements to clinical outcomes, (3) integrate data from multiple domains to identify sub-phenotypes 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 officially ended. CWRU investigators will work closely with the Scientific and Data Coordinating Center and other CRIC investigators to 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.