Chronic kidney disease (CKD) has become an important public health challenge in the United States. CKD 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 and associated CVD 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 a NIDDK-sponsored multi-center prospective cohort study. The overall objective of the CRIC study is to investigate novel risk factors for the progression of CKD and development of CVD among patients with chronic renal insufficiency. The CRIC study has recruited 3,612 adult patients with CKD from 7 clinical centers in the US. The study participants are followed for renal and cardiovascular outcomes up to 5 years in the initial phase (CRIC phase-1). The CRIC Tulane Clinical Center recruited 405 study participants and achieved a respective follow-up rate despite devastation caused by hurricane Katrina in the New Orleans area. The proposed CRIC phase-2 which extends follow-up through 2013, offers a unique opportunity to leverage the existing effort and success of CRIC to establish a cohort of CKD participants who have long-term prospective follow-up on progression of kidney disease and a variety of different outcomes. This unparalleled resource will also expand the science related to CKD natural history as well as the impact on CVD and other adverse events.
Specific aims to be addressed by the Tulane Clinical Center are: (1). to re-enroll a high percentage of CRIC phase-1 participants into phase-2;(2). to collect exposure and outcome data per the CRIC phase 1 and 2 protocols;(3). to maintain high levels of retention in the study;(4). to investigate self-reported clinical events and obtain supporting medical records and documentation;(5). to enter data and process/ship biological specimens;(6). to implement local quality assurance and quality control procedures as a means to obtain standardized, high quality measurements;(7). to monitor data collection, data entry, and follow-up rates;(8). to participate in governance and oversight of the CRIC study through study-wide subcommittees and activities;(9). to publish and present findings from the CRIC Study;and (10). to promote and support the conduct of ancillary studies in CRIC, including collaboration with the broader nephrology research community. The proposed study may provide insights into the underlying etiology of progression of CKD and related CVD and information for developing further intervention studies aimed at reducing morbidity and mortality of ESRD and CVD among patients with CKD.
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