Chronic Renal Insufficiency Cohort Limited competition continuation

项目摘要 凯斯西储大学（CWRU）建议继续作为临床中心的5期， 慢性肾功能不全队列研究（CRIC）慢性肾脏病（CKD）影响超过3700万人 有进展为终末期肾病和心血管疾病风险的美国人 疾病和其他与残疾有关的合并症、高昂的护理费用和过早死亡。以来 自2001年开始，CRIC研究招募并跟踪了5，625名种族和民族多样化的队列 来自美国7个临床中心的13个招募地点的肾功能降低的参与者。的 CRIC的最初目的是建立一个临床研究实验室，旨在（a）确定新的预测因子， CKD进展，和（B）表征心血管疾病的表现并识别其风险因素 在CKD患者中。作为CKD的里程碑式前瞻性队列研究，CRIC研究 完成了广泛的生物学、生理学和社会表型分析，纵向随访， 确定多个领域的临床和以患者为中心的结局。审评委的结论 研究定义了CKD进展的轨迹，并对以下疾病的发展和演变进行了分类： CKD，并确定了一系列不同的因素和途径，解释进展和并发症， 成人CKD。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 扩大在最近的资助周期（第4阶段：2018-2023年），三项创新子方案研究 通过对肾功能进行高度精细的家庭评估来丰富CRIC数据， 心血管检查在审评委研究的第五阶段即最后阶段，主要重点是（1） 确定所有受试者的临床结局，包括入组4期子方案的受试者，（2） 执行将子协议测量与临床结果相关联的分析，（3）整合来自多个 确定CKD进展结局异质性的亚表型，（4）进行 对符合第五阶段条件的审评委全部队列进行最后研究访问，（5）为今后的数据收集建立机制 通过与外部卫生数据来源的联系，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，由一个广泛的调查小组对审评委的数据和生物标本进行审查。 CWRU调查人员将与科学和数据协调中心以及其他CRIC密切合作。 研究人员产生新的科学产出，并成功地将审评委的研究从其积极的 前瞻性队列阶段，以支持持续和未来的机制， 流行病学和转化调查。

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.