SDCC - Prospective Cohort Study of Chronic Renal Insufficiency (NCT00304148)
Prospective Cohort Study of Chronic Renal Insufficiency
🩺 Plain-English Summary (8th-Grade Level)
Chronic kidney disease (CKD) is a silent epidemic affecting more than 37 million Americans. The burden of morbidity and mortality associated with CKD derives from its frequent progression to end-stage kidney disease (ESKD) and the disproportionate risk of cardiovascular disease (CVD) and associated complications. CKD is strongly and independently associated with CVD, even after adjustment for traditional CVD risk factors. This led to the hypothesis that other risk factors augment the rate of CVD in the setting of CKD. Hence, many patients with progressive renal disease succumb to fatal CVD events before they need renal replacement therapy. The National Institute of Diabetes, Digestive, and Kidney Diseases (NIDDK) established the Chronic Renal Insufficiency Cohort (CRIC) Study in 2001 with the initial goal of elucidating the relationship between CKD and CVD. Since its inception, the CRIC Study has recruited and followed a racially and ethnically diverse cohort of over 5,000 participants with reduced kidney function from 13 clinical recruitment sites across the US. The original aim of CRIC was to establish a clinical research laboratory designed to (a) identify novel predictors of CKD progression, and (b) characterize the manifestations of CVD and identify its risk factors among individuals with CKD. The CRIC Study has examined a broad set of etiological factors (clinical, behavioral, and biomarker-associated) potentially responsible for both progressive CKD and CKD-related morbidities, especially those early in the course of CKD. Characterizing relationships between these risk factors and outcomes should facilitate identification of high-risk subgroups with CKD and guide enrollment into preventive treatment trials and application of preventive therapies. Over time, the scientific focus and the CRIC investigator network have broadened extensively through a highly successful ancillary studies program that has included more than 100 projects, most of which have been funded through federal grants. To date, the CRIC Study's investigative activities have resulted in over 300 published scientific papers with many additional manuscripts in development.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (16 items).
Location: Kaiser Permanente of Northern California — Oakland, California
Age range: 21 Years to 79 Years
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Unable or unwilling to provide informed consent
- Previously received dialysis (peritoneal and/or hemodialysis) lasting more than one month
- Prior organ or bone marrow transplant
- Prior renal transplant
- Received immunosuppressive or other immunotherapy for primary renal disease or systemic vasculitis that affects the kidneys (i.e., anti-GCM, ANCA, SLE, IgA nephropathy, cryoglobulin, etc.) within the past six months before enrollment
- Received chemotherapy or alkylating agents for systemic cancer
- Known cirrhosis
- NYHA Class III or IV heart failure at baseline
- Previous diagnosis of multiple myeloma or renal carcinoma
- Previously diagnosed polycystic kidney disease
- Known HIV infection and/or AIDS
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (12 Sites)
- Kaiser Permanente of Northern California — Oakland, California
- University of California — San Francisco, California
- University of Illinois at Chicago — Chicago, Illinois
- Tulane University Health Sciences Center — New Orleans, Louisiana
- University of Maryland Medical System — Baltimore, Maryland
- Johns Hopkins Medical Institutions — Baltimore, Maryland
- University of Michigan Hospitals — Ann Arbor, Michigan
- Wayne State - Harper University Hospital — Detroit, Michigan
- University Hospitals of Cleveland — Cleveland, Ohio
- Metrohealth Medical Center — Cleveland, Ohio
- Cleveland Clinic Foundation — Cleveland, Ohio
- University of Pennsylvania Medical Center — Philadelphia, Pennsylvania
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.