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NCT00304148Active, not recruiting

SDCC - Prospective Cohort Study of Chronic Renal Insufficiency

Prospective Cohort Study of Chronic Renal Insufficiency

Source: ClinicalTrials.gov · Last updated 14 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
5499 (estimated)
First submitted
14 Mar 2006
Start date
Jul 2003
Primary completion date
Jun 2028
Lead sponsor
University of Pennsylvania
NCT number
NCT00304148

What you commit to

  • Study type: Observational
  • Planned participants: 5499
  • From Jul 2003 to the primary completion date, Jun 2028
  • 12 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • Previous diagnosis of multiple myeloma or renal carcinoma
  • Previously diagnosed polycystic kidney disease

Other illness

  • NYHA Class III or IV heart failure at baseline
  • Known HIV infection and/or AIDS

Other

  • Unable or unwilling to provide informed consent
  • Known cirrhosis
  • 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.

Who the study is looking for

  • 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

Age in the registry: 21 years to 79 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (12)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Michigan Hospitals
Coordinator of this site? Confirm its status
Ann ArborUnited StatesUnknown status
University of Maryland Medical System
Coordinator of this site? Confirm its status
BaltimoreUnited StatesUnknown status
Johns Hopkins Medical Institutions
Coordinator of this site? Confirm its status
BaltimoreUnited StatesUnknown status
University of Illinois at Chicago
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
University Hospitals Of Cleveland
Coordinator of this site? Confirm its status
ClevelandUnited StatesUnknown status
MetroHealth Medical Center
Coordinator of this site? Confirm its status
ClevelandUnited StatesUnknown status
Cleveland Clinic Foundation
Coordinator of this site? Confirm its status
ClevelandUnited StatesUnknown status
Wayne State - Harper University Hospital
Coordinator of this site? Confirm its status
DetroitUnited StatesUnknown status
Tulane University Health Sciences Center
Coordinator of this site? Confirm its status
New OrleansUnited StatesUnknown status
Kaiser Permanente of Northern California
Coordinator of this site? Confirm its status
OaklandUnited StatesUnknown status
University of Pennsylvania Medical Center
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesUnknown status
University of California
Coordinator of this site? Confirm its status
San FranciscoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.