SDCC - Prospective Cohort Study of Chronic Renal Insufficiency

Running, not enrolling

Conditions studied: Renal Insufficiency, Chronic

In brief

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.

Key facts

Study ID

NCT00304148

Run by

University of Pennsylvania

People needed

5499

Starts

2003-07-01

Expected to finish

2028-06-01

Last updated by the study team

2026-06-26

Who can join

Age: 21 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• During the screening visit a blood sample will be tested to indirectly check kidney function based on the serum creatinine level:
• Age Range: 21 - 79 years
• Estimated Glomerular Filtration Rate (GFR): 45 - 70 mL/min/1.73m²
• Proteinuria: varies dependent on eGRF

You may not qualify if…

• 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
• Pregnant or breast-feeding women
• Currently participating in an interventional clinical trial (i.e., primarily trials of therapeutic agents that may have an effect on renal or cardiovascular outcomes).
• Institutionalized (e.g., prisoner, nursing home resident, skilled nursing facility resident)
• Appears unlikely or unable to participate in the required study procedures as assessed by the investigator, study coordinator or designee.

Where it is running

• Kaiser Permanente of Northern California — Oakland, California, United States
• University of California — San Francisco, California, United States
• University of Illinois at Chicago — Chicago, Illinois, United States
• Tulane University Health Sciences Center — New Orleans, Louisiana, United States
• University of Maryland Medical System — Baltimore, Maryland, United States
• Johns Hopkins Medical Institutions — Baltimore, Maryland, United States
• University of Michigan Hospitals — Ann Arbor, Michigan, United States
• Wayne State - Harper University Hospital — Detroit, Michigan, United States
• University Hospitals of Cleveland — Cleveland, Ohio, United States
• Metrohealth Medical Center — Cleveland, Ohio, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• University of Pennsylvania Medical Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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