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NCT00324571 · ClinicalTrials.gov registry record · Phase 4
Dialysis Clinical Outcomes Revisited (DCOR) Trial
A Phase 4 study of Chronic Kidney Disease, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 2,000
- Enrollment target
- 20
- Study locations
NCT00324571: Completed Phase 4 study of Chronic Kidney Disease, sponsored by Genzyme, a Sanofi Company.
NCT00324571 is a Phase 4 study of Chronic Kidney Disease that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 2,000 participants, below the 3,187-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (37% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00324571, a Phase 4 study of Chronic Kidney Disease, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 2,000 participants
- Enrollment target
- 20
- Study locations
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 |
What the finished NCT00324571 record still lists
NCT00324571 is an interventional study that assigns participants to a tested intervention. Its 2,000 participants enrollment target places it among the larger protocols in the corpus, below the 3,187-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (37% lower).
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.
NCT00324571 names 20 study sites across 6 states, led by Florida, California, Connecticut.
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.
What interventions are being tested in trial NCT00324571?
The interventions under investigation include: Sevelamer hydrochloride (DRUG), Calcium-based phosphate binder (DRUG).
Who is sponsoring clinical trial NCT00324571?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00324571's enrollment target sits among peer trials
2,000 13th of 101 higher than 88 of 101 other Chronic Kidney Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Kidney Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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