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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 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.

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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

Chronic Kidney Disease

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

FieldValue
Enrollment Target 2,000 participants
Start Date 2001-03
Est. Completion 2006-02
Phase Phase 4

Sponsor

Genzyme, a Sanofi Company

196 total trials

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What the Registry Record Tells You About NCT00324571

The ClinicalTrials.gov registry entry for NCT00324571 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 2,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,187-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (37% lower). The listed sponsor is Genzyme, a Sanofi Company, which has 196 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.