Dialysis Clinical Outcomes Revisited (DCOR) Trial

March 17, 2015 updated by: Genzyme, a Sanofi Company

A Randomized, Open Label, Parallel Design Study of Renagel® Phosphate Binder Versus Calcium-Based Phosphate Binders in Hemodialysis Patients

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.

Study Overview

Study Type

Interventional

Enrollment

2000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • San Juan, Puerto Rico
        • Clinical Las Americas
    • Alabama
      • Gadsden, Alabama, United States
        • Gambro Healthcare-Gadsden
      • Huntsville, Alabama, United States
        • nTouch Research
    • Arizona
      • Tucson, Arizona, United States
        • Kidney Health Institute, LLC
    • California
      • El Cerrito, California, United States
        • Gambro Healthcare
      • Escondido, California, United States
        • Palomar Medical Group
      • Los Angeles, California, United States
        • Gambro Healthcare-Los Angeles
      • San Diego, California, United States
        • Balboa Nephrology Medical Group
      • Tarzana, California, United States
        • Nephrology Educational Services and Research
    • Colorado
      • Denver, Colorado, United States
        • Lowry Dialysis Center
    • Connecticut
      • Bridgeport, Connecticut, United States
        • Nephrology Associates, P.C.
      • Hartford, Connecticut, United States
        • Gambro Healthcare-Hartford
      • New Britain, Connecticut, United States
        • Nephrology Associates
    • Florida
      • Coral Gables, Florida, United States
        • InterAmerican Dialysis
      • Crystal River, Florida, United States
        • DaVita Crystal River Dialysis
      • Miami, Florida, United States
        • Gambro Healthcare-Miami
      • Miami, Florida, United States
        • Miami Kidney Group
      • Pensacola, Florida, United States
        • Pensacola Nephrology, P.A.
      • Plantation, Florida, United States
        • Gambro Healthcare-Plantation
      • St. Petersburg, Florida, United States
        • America Dialysis
      • Tampa, Florida, United States
        • Genesis Clinical Research Corp
    • Georgia
      • Americus, Georgia, United States
        • Gambro Healthcare-Americus
      • Atlanta, Georgia, United States
        • nTouch Research
      • Douglas, Georgia, United States
        • Gambro Healthcare-Douglas
      • Douglasville, Georgia, United States
        • Gambro Healthcare-Douglasville
      • Dublin, Georgia, United States
        • Dublin Nephrology
      • Marietta, Georgia, United States
        • Georgia Kidney Associates, Inc.
      • Rome, Georgia, United States
        • Gambro Healthcare-Rome
      • Savannah, Georgia, United States
        • Gambro Healthcare-Savannah
    • Illinois
      • Berwyn, Illinois, United States
        • MacNeal Renal Lifeline Services
      • Evergreen Park, Illinois, United States
        • Southwest Nephrology
      • Olympia Fields, Illinois, United States
        • Horizon Healthcare Associates
      • Peoria, Illinois, United States
        • Renal Care Associates, S.C.
      • Springfield, Illinois, United States
        • Gambro Healthcare-Springfield Central
      • Springfield, Illinois, United States
        • Lincolnland Dialysis
    • Indiana
      • Valparaiso, Indiana, United States
        • Nephrology Specialists, PC.
    • Kansas
      • Wichita, Kansas, United States
        • Wichita Dialysis Center East
      • Wichita, Kansas, United States
        • Wichita Nephrology
    • Louisiana
      • Shreveport, Louisiana, United States
        • Northwest Louisiana Nephrology, LLC.
    • Maryland
      • Bethesda, Maryland, United States
        • BMA of Washington
      • Frederick, Maryland, United States
        • Gambro Healthcare-Frederick
    • Massachusetts
      • Brockton, Massachusetts, United States
        • Associates in Nephrology, P.C.
      • Springfield, Massachusetts, United States
        • Western New England Renal and Transplant Associates, Inc.
    • Minnesota
      • Minneapolis, Minnesota, United States
        • Davita Clinical Research
    • Mississippi
      • Columbus, Mississippi, United States, 39705
        • Nephrology Associates, P.C.
    • Missouri
      • Kansas City, Missouri, United States
        • University of Missouri-Kansas City
      • St. Louis, Missouri, United States
        • DaVita Crystal City Dialysis
    • Nevada
      • Las Vegas, Nevada, United States
        • Nephrology and Endocrine Associates
    • New York
      • Bronx, New York, United States
        • Bronx Westchester Medical Group
    • North Carolina
      • Asheville, North Carolina, United States
        • Mountain Kidney Associates, P.A.
      • Raleigh, North Carolina, United States
        • nTouch Research
      • Raleigh, North Carolina, United States
        • Wake Nephrology/Wake Dialysis Clinic
      • Wilson, North Carolina, United States
        • Gambro Healthcare-Wilson
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Kidney and Hypertension Center
      • Columbus, Ohio, United States
        • Ohio State University College of Pharmacy
    • Pennsylvania
      • Allentown, Pennsylvania, United States
        • FMC of Bethlehem
      • Greensburg, Pennsylvania, United States
        • Fresenius Medical Care
      • Lancaster, Pennsylvania, United States
        • Hypertension and Kidney Specialists
      • Lewistown, Pennsylvania, United States
        • DaVita Lewistown Dialysis Center
      • Philadelphia, Pennsylvania, United States, 19141
        • Albert Einstein Medical Center
      • Philadelphia, Pennsylvania, United States
        • P.C. & Associates
      • Wilkes-Barre, Pennsylvania, United States
        • Nesbitt College of Pharmacy and Nursing Department of Pharmacy Practice
    • South Carolina
      • Aiken, South Carolina, United States
        • Gambro Healthcare-Aiken
    • Tennessee
      • Memphis, Tennessee, United States
        • Midsouth Nephrology Consultants
    • Texas
      • Dallas, Texas, United States
        • Dallas Nephrology Associates
      • Houston, Texas, United States
        • Nephrology, Dialysis and Transplant Association
      • Houston, Texas, United States
        • West Houston Dialysis
      • San Antonio, Texas, United States
        • San Antonio Kidney Disease Center
    • Virginia
      • Charlottesville, Virginia, United States, 22902
        • Gambro Healthcare - Charlottesville
      • Fairfax, Virginia, United States
        • Clinical Research and Consulting Center, LLC
      • Norfolk, Virginia, United States, 23507
        • Clinical Research of Tidewater
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University, Division of Nephrology
    • Washington
      • Vancouver, Washington, United States
        • Vancouver Clinic Inc., P.S.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients must be 18 years of age or older,
  • on dialysis for more than 3 months,
  • require phosphate binder therapy,
  • have Medicare as their primary insurance.

Exclusion Criteria:

  • dysphagia,
  • swallowing disorders,
  • severe gastrointestinal motility disorders,
  • bowel obstruction.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Efficacy will be evaluated based on a comparison of the association of Renagel use versus calcium-based phosphate binder use on all-cause mortality, cause-specific mortality (cardiovascular, infection, other), and all-cause hospitalization.
Safety will be assessed based on an evaluation of related serious adverse events.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2001

Primary Completion

December 6, 2022

Study Completion

February 1, 2006

Study Registration Dates

First Submitted

May 9, 2006

First Submitted That Met QC Criteria

May 9, 2006

First Posted (Estimate)

May 11, 2006

Study Record Updates

Last Update Posted (Estimate)

March 18, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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