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Dialysis Clinical Outcomes Revisited (DCOR) Trial
NCT00324571 · View on ClinicalTrials.gov ↗
Study Summary
This is a randomized, open-label, parallel-design study to be conducted at 75 centers within the United States. The study will be described to hemodialysis patients. Informed consent will be obtained and the inclusion/exclusion criteria reviewed. Eligible patients will be randomized to receive either Renagel or a calcium-based binder. Starting from the randomization date, mortality data including survival, death date and cause of death (vital status information) and morbidity data including hospitalization date will be recorded for all patients. These data will be collected until the end of the study (December 31, 2004, ± 2 weeks). Patients completing or terminating from the study will return to the phosphate binder prescribed by their usual healthcare provider.
Conditions Studied
Interventions
- DRUG Sevelamer hydrochloride
- DRUG Calcium-based phosphate binder
Study Locations (20)
Florida
- InterAmerican Dialysis — Coral Gables
- DaVita Crystal River Dialysis — Crystal River
- Gambro Healthcare-Miami — Miami
- Miami Kidney Group — Miami
- Pensacola Nephrology, P.A. — Pensacola
- Gambro Healthcare-Plantation — Plantation
- America Dialysis — St. Petersburg
- Genesis Clinical Research Corp — Tampa
California
- Gambro Healthcare — El Cerrito
- Palomar Medical Group — Escondido
- Gambro Healthcare-Los Angeles — Los Angeles
- Balboa Nephrology Medical Group — San Diego
- Nephrology Educational Services and Research — Tarzana
Connecticut
- Nephrology Associates, P.C. — Bridgeport
- Gambro Healthcare-Hartford — Hartford
- Nephrology Associates — New Britain
Alabama
- Gambro Healthcare-Gadsden — Gadsden
- nTouch Research — Huntsville
Arizona
- Kidney Health Institute, LLC — Tucson
Colorado
- Lowry Dialysis Center — Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,000 participants |
| Start Date | 2001-03 |
| Est. Completion | 2006-02 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00324571
The ClinicalTrials.gov registry entry for NCT00324571 describes a study currently listed as completed. It is categorized as Phase 4, 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 2,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genzyme, a Sanofi Company, which has 52 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 Chronic Kidney Disease appearing as the primary indexed condition, and to 2 interventions — of which Sevelamer hydrochloride is the first listed. 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: NCT00324571 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Florida, California, Connecticut. 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 NCT00324571 about?
NCT00324571 is a clinical study titled "Dialysis Clinical Outcomes Revisited (DCOR) Trial". This is a randomized, open-label, parallel-design study to be conducted at 75 centers within the United States. The study will be described to hemodialysis patients. Informed consent will be obtained and the inclusion/exclusion criteria reviewed. Eligible patients will be randomized to receive eithe...
What is the current status of trial NCT00324571?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 2,000 participants. The study started on 2001-03. Estimated completion is 2006-02.
What conditions does trial NCT00324571 study?
This clinical trial studies the following conditions: Chronic Kidney Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00324571?
The interventions under investigation include: Sevelamer hydrochloride (DRUG), Calcium-based phosphate binder (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00324571?
This trial is sponsored by Genzyme, a Sanofi Company, which has 52 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00324571 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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