Dialysis Clinical Outcomes Revisited (DCOR) Trial

This study has been completed.
Sponsor:
Information provided by:
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00324571
First received: May 9, 2006
Last updated: July 29, 2009
Last verified: May 2006
  Purpose

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.


Condition Intervention Phase
Chronic Kidney Disease
Drug: Sevelamer hydrochloride
Drug: Calcium-based phosphate binder
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open Label, Parallel Design Study of Renagel® Phosphate Binder Versus Calcium-Based Phosphate Binders in Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by Genzyme, a Sanofi Company:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 2000
Study Start Date: March 2001
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00324571

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

Additional Information:
No publications provided

Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00324571     History of Changes
Other Study ID Numbers: GTC-68-401
Study First Received: May 9, 2006
Last Updated: July 29, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
Sevelamer
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014