Between 2002-2008, the Chronic Renal Insufficiency Cohort (CRIC) Study enrolled 3,939 adults with chronic kidney disease (CKD) at 7 Clinical Centers to address overarching goals of identifying risk factors for CKD progression and clarifying the relationship between kidney dysfunction and the risks of subclinical and clinical cardiovascular events and mortality. Phase 2 of CRIC extended follow-up through April 30, 2013. This application is submitted in response to RFA-DK-12-508, Limited Competition for the Continuation of the Chronic Renal Insufficiency Cohort (CRIC) Study (U01), on behalf of the Hopkins and University of Maryland (U.MD) Clinical Center. In Phase 3, the Hopkins/U.MD center has the following specific aims: 1. To re-enroll current participants [total of ~362 (203 a Hopkins, 159 at U.MD)] 2. To enroll an additional 215 participants into Phase 3 of CRIC 3. To collect exposure and outcome data per the CRIC Phase 3 protocol 4. To maintain high levels of retention in the study 5. To investigate self-reported clinical events and obtain supporting medical records and documentation. 6. To enter data and collect/process/ship biological specimens. 7. To implement local quality assurance and quality control procedures as a means to obtain standardized, high quality measurements 8. To monitor data collection, data entry, and follow-up rates 9. To participate in governance and oversight of CRIC through study wide subcommittees and activities 10. To publish and present findings from the CRIC Study 11. To promote and support the conduct of ancillary studies in CRIC, including collaboration with the broader nephrology research community. The investigative teams at Hopkins and U.MD have vast experience in the design and implementation of rigorously conducted, influential research. During Phases 1+2, the Hopkins and U.MD Center was a high performing center that exceeded its recruitment goal; achieved high follow-up rates; and collected high quality data. Likewise, center investigators have consistently had prominent leadership roles (e.g. Co-Chairs of Recruitment and Retention, Ancillary Studies, and Publications Executive Subcommittees). In Phase 3, we remain extremely well-positioned to successfully implement the study. On a final note, we remain deeply committed to the success of CRIC and look forward to providing strong scientific leadership in this tremendously important research effort.

Public Health Relevance

Chronic Kidney Disease is an extremely common medical problem. The consequences of chronic kidney disease include kidney failure requiring dialysis or a kidney transplant; cardiovascular disease and stroke; physical and cognitive disabilities; and premature death. The Chronic Renal Insufficiency Cohort (CRIC) Study is a long-term, observational study designed to evaluate factors that might be responsible for these adverse outcomes in adults with chronic kidney disease.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
4U01DK061022-16
Application #
9070450
Study Section
Special Emphasis Panel (ZDK1)
Program Officer
Kusek, John W
Project Start
2001-09-28
Project End
2018-04-30
Budget Start
2016-05-01
Budget End
2017-04-30
Support Year
16
Fiscal Year
2016
Total Cost
Indirect Cost
Name
Johns Hopkins University
Department
Public Health & Prev Medicine
Type
Schools of Public Health
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21205
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Grams, Morgan E; Sang, Yingying; Ballew, Shoshana H et al. (2018) Predicting timing of clinical outcomes in patients with chronic kidney disease and severely decreased glomerular filtration rate. Kidney Int 93:1442-1451
Cedillo-Couvert, Esteban A; Hsu, Jesse Y; Ricardo, Ana C et al. (2018) Patient Experience with Primary Care Physician and Risk for Hospitalization in Hispanics with CKD. Clin J Am Soc Nephrol 13:1659-1667
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Bundy, Joshua D; Bazzano, Lydia A; Xie, Dawei et al. (2018) Self-Reported Tobacco, Alcohol, and Illicit Drug Use and Progression of Chronic Kidney Disease. Clin J Am Soc Nephrol 13:993-1001
Grams, Morgan E; Shafi, Tariq; Rhee, Eugene P (2018) Metabolomics Research in Chronic Kidney Disease. J Am Soc Nephrol 29:1588-1590
Bansal, Nisha; Xie, Dawei; Sha, Daohang et al. (2018) Cardiovascular Events after New-Onset Atrial Fibrillation in Adults with CKD: Results from the Chronic Renal Insufficiency Cohort (CRIC) Study. J Am Soc Nephrol 29:2859-2869
Harhay, Meera N; Xie, Dawei; Zhang, Xiaoming et al. (2018) Cognitive Impairment in Non-Dialysis-Dependent CKD and the Transition to Dialysis: Findings From the Chronic Renal Insufficiency Cohort (CRIC) Study. Am J Kidney Dis 72:499-508

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