Tulane Clinical Center for Chronic Renal Insufficiency Cohort Study

PROJECT SUMMARY Chronic kidney disease (CKD) affects over 37 million Americans and increases the risk of end stage kidney disease, cardiovascular disease, and premature mortality. Since its inception in 2001, the Chronic Renal Insufficiency Cohort (CRIC) Study has recruited and followed a racially and ethnically diverse cohort of 5,625 participants with reduced kidney function at 7 Clinical Centers across the US. The original aim of CRIC was to identify novel risk factors for CKD progression and cardiovascular disease 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 the 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 the ongoing use of CRIC data and biospecimens by a broad group of investigators after the study’s official end. To achieve the above goals, the Tulane CRIC Clinical Center will reconsent and reenroll a high proportion of the 278 active study participants into CRIC Phase 5; complete study visits and data collection with a stringent quality control process; actively develop and participate in Ancillary Studies; maximize scientific productivity by leading and participating in scientific presentations and publications; network with non-CRIC Study researchers to integrate CRIC data with non-CRIC data to increase scientific output; provide training opportunities for the next generation of researchers; and facilitate linkages between participant-level CRIC data and key external data sources to enable the acquisition of additional data for future investigations. These proposed activities 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.