Between 2001-2013, the NIDDK sponsored Phases I and II of the Chronic Renal Insufficiency Cohort (CRIC) Study in which approximately 3,600 multiethnic, adult participants were enrolled from seven clinical centers and their satellites alon with an additional 326 participants of Hispanic ethnicity with chronic kidney disease (CKD) from one clinical center. The cumulative total of 3,939 study participants has been followed for up to 11 years during which we aimed to: (1) examine the risk factors for CKD progression and cardiovascular disease (CVD);(2) develop predictive models to identify high risk subgroups;and (3) identify etiological factors as targets for clinical trial interventions. The goals of the current application are to: (1) continue the follow-up of the originally recruited CRIC cohort;(2) study the relationship between CKD and outcomes in the elderly;(3) conduct a comprehensive assessment of the morbidity experienced by participants with CKD including non- CVD clinical outcomes and non-CVD hospitalizations;and (4) recruit and prospectively evaluate the CKD and CVD outcomes in participants with CKD stage 2 and 3a (mild/moderate CKD). 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 University of Michigan Health Systems (UMHS), Wayne State University School of Medicine (WSU) and St. Clair Specialty Physicians (SCSP) of the St. Johns Providence Health System which have functioned together as the Michigan CRIC Clinical Center (Clinical Center 04) in CRIC Phases I and II from 2001 to 2013. In CRIC Phase III, the Michigan CRIC Clinical Center will undertake the following specific aims: 1. To re-enroll e90 percent of eligible of CRIC Phase II study participants into the Phase III of the CRIC study 2. To enroll an additional 215 participants into CRIC Phase III 3. To collect exposure and outcome data as specified in the CRIC Phase III protocol 4. To maintain high levels of retention of participants in the study 5. T investigate self-reported clinical events and obtain supporting medical records and documentation 6. To enter data into the centralized Data Management System and to process and ship biological specimen to the Scientific and Data Coordinating Center 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. It is estimated that 395 of the Michigan CRIC Phase II participants will be eligible to participate in CRIC Phase III. Our Clinical Center will enroll 215 new participants wit mild/moderate CKD from the University of Michigan Health System (n=124), the Hospitals of the Wayne State University School of Medicine (n=65) and the St. Clair Specialty Physicians (n=26) into an aggregate total of 1,500 new participants to be enrolled study-wide. In addition, we will execute a prospective assessment of morbidity and causes of hospitalization and resource utilization in all the participants retained from CRIC Phase II and the new participants recruited into CRIC Phase III in order to accomplish the new study aims planned for Phase III. Our Clinical Center will cooperate with other CRIC study awardees and the NIDDK in the implementation of study protocols and procedures to accomplish the specific aims outlined above.
This project will study nearly 4,000 patients to better understand the factors and pathways leading to end stage kidney failure, cardiovascular disease and premature death in individuals with diminished kidney function. Understanding the mechanism of progression of chronic kidney disease and its relationship to cardiovascular disease will advance the Objective 4-1 of Health People 2010 to improve the renal health of Americans.
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