Project Summary/Abstract Chronic kidney disease (CKD) is an important public health challenge because it is a major risk factor for end-stage renal disease (ESRD), cardiovascular disease (CVD), and premature death. Understanding novel risk factors for the progression of CKD, CVD, and other related comorbidities may help to develop effective approaches for early intervention in order to reduce the adverse disease burden. The Chronic Renal Insufficiency Cohort (CRIC) Study is an NIDDK-sponsored multicenter prospective study designed to investigate novel risk factors for the progression of CKD and development of CVD among patients with CKD. The CRIC Study recruited 3,939 patients with CKD from 7 Clinical Centers in phase 1 and an additional 1,560 patients in phase 3. The CRIC Tulane Clinical Center recruited 405 participants in phase 1 and 253 participants in phase 3 and achieved the highest follow-up rate among all clinical centers despite the devastation caused by Hurricane Katrina in the New Orleans area. In CRIC phase 4, we propose to expand the study's scope to implement novel remote data capture technologies in sub-groups of study participants to determine sub-clinical acute declines in kidney function and to identify novel CVD phenotypes. Specific aims to be addressed in phase 4 by the Tulane Clinical Center are: 1. To re-enroll a high percentage of existing participants and obtain study data in these participants; 2. To maintain high levels of participant retention; 3. To identify novel CVD phenotypes using remotely collected data and determine their relationship to clinical outcomes; 4. To examine sub-clinical acute declines in kidney function using remotely collected data and determine their relationship to clinical outcomes; 5. To investigate self-reported CVD and renal events and obtain supporting medical records and documentation; 6. To implement effective local quality assurance and quality control procedures to ensure standardized, high-quality measurements; 7. To participate in governance and oversight of CRIC through study-wide subcommittees and activities; 8. To publish and present findings from the CRIC Study, including integrative and other high-impact manuscripts; 9. To conduct approved CRIC ancillary studies; 10. To utilize state-of-the-art methods in biostatistics and bioinformatics to analyze complex, longitudinal datasets incorporating a multitude of exposure and outcome variables; 11. To engage investigators at the Tulane Clinical Center to assist in local analysis of CRIC data, to develop and conduct ancillary studies, and to participate in parent study activities; and 12. To engage investigators in the broader scientific community to participate in the CRIC Study. The proposed research has important public health and clinical implications. The study findings may reveal novel and reversible underlying etiologic factors for the progression of CKD, CVD, and other related comorbid outcomes. This information will be useful to develop further intervention studies aimed at reducing total morbidity and mortality burdens among patients with CKD.

Project Narrative The Chronic Renal Insufficiency Cohort (CRIC) Study is an NIDDK-sponsored multicenter prospective cohort study investigating novel risk factors for the progression of chronic kidney disease and cardiovascular disease among patients with chronic kidney disease. The CRIC study may provide insights into the underlying etiology and information for developing further intervention studies aimed at reducing the total morbidity and mortality burdens among patients with chronic kidney disease.