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ACTIVE NOT RECRUITING

SDCC - Prospective Cohort Study of Chronic Renal Insufficiency

NCT00304148 · View on ClinicalTrials.gov ↗

Study Summary

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 fu

Study Locations (12)

Ohio

  • University Hospitals of Cleveland — Cleveland
  • Metrohealth Medical Center — Cleveland
  • Cleveland Clinic Foundation — Cleveland

California

  • Kaiser Permanente of Northern California — Oakland
  • University of California — San Francisco

Maryland

  • University of Maryland Medical System — Baltimore
  • Johns Hopkins Medical Institutions — Baltimore

Michigan

  • University of Michigan Hospitals — Ann Arbor
  • Wayne State - Harper University Hospital — Detroit

Illinois

  • University of Illinois at Chicago — Chicago

Louisiana

  • Tulane University Health Sciences Center — New Orleans

Pennsylvania

  • University of Pennsylvania Medical Center — Philadelphia

Trial Details

FieldValue
Enrollment Target 5,499 participants
Start Date 2003-07
Est. Completion 2028-06

Sponsor

University of Pennsylvania

1,457 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00304148

The ClinicalTrials.gov registry entry for NCT00304148 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 5,499 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,457 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Renal Insufficiency, Chronic appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00304148 reports 12 study locations spanning 7 distinct geographic areas — top geographies include Ohio, California, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00304148 about?

NCT00304148 is a clinical study titled "SDCC - Prospective Cohort Study of Chronic Renal Insufficiency". 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 ...

What is the current status of trial NCT00304148?

This trial is currently active not recruiting. The enrollment target is 5,499 participants. The study started on 2003-07. Estimated completion is 2028-06.

What conditions does trial NCT00304148 study?

This clinical trial studies the following conditions: Renal Insufficiency, Chronic. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

Who is sponsoring clinical trial NCT00304148?

This trial is sponsored by University of Pennsylvania, which has 1,457 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00304148 being conducted?

This trial has 12 study locations across California, Illinois, Louisiana, Maryland, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial