Prospective renal insufficiency cohort evaluation: PRICE

项目摘要 本申请是根据RFA-DK-22-502“有限竞争：继续”提交的 慢性肾功能不全队列（CRIC）研究（U 01）”的报告， 宾夕法尼亚州（Penn）临床中心。慢性肾脏病（CKD）影响超过3700万人 有进展为终末期肾病和发展为 心血管疾病（CV）和其他与残疾相关的合并症， 护理和过早死亡。自2001年启动以来，审评委的研究招募了 对5,625名不同种族的肾功能减退患者进行了随访， 在美国7个临床中心的13个招募中心发挥作用。宾夕法尼亚大学的网站有 为审评委作出了重大贡献，招募了723名与会者，占与会者总数的12.8%。原始 审评委的目标是建立一个临床研究实验室，旨在（a） CKD进展的预测因子，和（B）表征CV疾病的表现， 确定CKD患者中的风险因素。作为具有里程碑意义的前瞻性队列研究， CKD，CRIC研究已经完成了广泛的生物，生理和社会 表型分析、纵向随访以及确定临床和以患者为中心的 多个领域的成果。审评委研究的结果确定了 CKD进展，分类CKD合并症的发展和演变，并确定 解释CKD进展和并发症的多种因素和途径 在成年人中。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者群体 明显扩大。在最近一个供资周期（第四阶段：2018-2023年）， 开展了创新的次级议定书研究，以丰富审评委的数据， 肾功能评估和CV测量。在审评委第五阶段和最后阶段期间 研究的主要重点是（1）确定所有参与者的临床结果，包括 入组IV期子方案的患者，（2）进行与子方案相关的分析 （3）整合来自多个领域的数据，以确定 CKD进展结局异质性的潜在表型，（4）进行最终研究 对符合第五阶段条件的审评委全部群组进行访问，（5）建立今后数据的机制 通过与外部健康数据源的联系收集数据，以及（6）生成工具， 资源，以便利广大的缔约方不断使用审评委的数据和生物标本， 审评委研究正式结束后，

PROJECT SUMMARY This application is submitted in response to RFA-DK-22-502, “Limited Competition: Continuation of the Chronic Renal Insufficiency Cohort (CRIC) Study (U01)” on behalf of the University of Pennsylvania (Penn) Clinical Center. 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 (CV) 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 Penn site has contributed significantly to CRIC and recruited 723 or 12.8 % of the participants. 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 CV 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 home-based assessments of kidney function and CV 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.