GTC68401: Dialysis Clinical Outcomes Revisited (DCOR) Trial

This study has been completed.

Sponsored By:	Genzyme
Information Provided By:	Genzyme
ClinicalTrials.gov Identifier:	NCT00324571

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: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Further Study Details:

Primary Outcomes: 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.

Expected Total Enrollment: 2000

Study Start: 2001-03

Eligibility

Ages Eligible for Study: 18 Years - N/A, Genders Eligible for Study: Both

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.

Location Information

Alabama
Gambro Healthcare-Gadsden, Gadsden, Alabama, United States
nTouch Research, Huntsville, Alabama, United States

Arizona
Kidney Health Institute, LLC, Tucson, Arizona, United States

California
Gambro Healthcare, El Cerrito, California, United States
Nephrology Educational Services and Research, Tarzana, California, United States
Balboa Nephrology Medical Group, San Diego, California, United States
Gambro Healthcare-Los Angeles, Los Angeles, California, United States
Palomar Medical Group, Escondido, California, United States

Colorado
Lowry Dialysis Center, Denver, Colorado, United States

Connecticut
Gambro Healthcare-Hartford, Hartford, Connecticut, United States
Nephrology Associates, New Britain, Connecticut, United States
Nephrology Associates, P.C., Bridgeport, Connecticut, United States

Florida
America Dialysis, St. Petersburg, Florida, United States
DaVita Crystal River Dialysis, Crystal River, Florida, United States
Gambro Healthcare-Miami, Miami, Florida, United States
Gambro Healthcare-Plantation, Plantation, Florida, United States
Genesis Clinical Research Corp, Tampa, Florida, United States
InterAmerican Dialysis, Coral Gables, Florida, United States
Miami Kidney Group, Miami, Florida, United States
Pensacola Nephrology, P.A., Pensacola, Florida, United States

Georgia
Dublin Nephrology, Dublin, Georgia, United States
Gambro Healthcare-Americus, Americus, Georgia, United States
Gambro Healthcare-Douglas, Douglas, Georgia, United States
Gambro Healthcare-Douglasville, Douglasville, Georgia, United States
Gambro Healthcare-Rome, Rome, Georgia, United States
Gambro Healthcare-Savannah, Savannah, Georgia, United States
Georgia Kidney Associates, Inc., Marietta, Georgia, United States
nTouch Research, Atlanta, Georgia, United States

Illinois
Horizon Healthcare Associates, Olympia Fields, Illinois, United States
Gambro Healthcare-Springfield Central, Springfield, Illinois, United States
Lincolnland Dialysis, Springfield, Illinois, United States
MacNeal Renal Lifeline Services, Berwyn, Illinois, United States
Renal Care Associates, S.C., Peoria, Illinois, United States
Southwest Nephrology, Evergreen Park, Illinois, United States
Indiana
Nephrology Specialists, PC., Valparaiso, Indiana, United States

Kansas
Wichita Dialysis Center East, Wichita, Kansas, United States
Wichita Nephrology, Wichita, Kansas, United States

Louisana
Northwest Louisiana Nephrology, LLC., Shreveport, Louisiana, United States

Maryland
BMA of Washington, Bethesda, Maryland, United States
Gambro Healthcare-Frederick, Frederick, Maryland, United States

Massachusetts
Associates in Nephrology, P.C., Brockton, Massachusetts, United States
Western New England Renal and Transplant Associates, Inc., Springfield, Massachusetts, United States

Minnesota
DaVita Clinical Research, Minneapolis, Minnesota, United States

Mississippi
Nephrology Associates, P.C., Columbus, Mississippi, 39705, United States

Missouri
DaVita Crystal City Dialysis, St. Louis, Missouri, United States
University of Missouri-Kansas City, Kansas City, Missouri, United States

Nevada
Nephrology and Endocrine Associates, Las Vegas, Nevada, United States

New York
Bronx Westchester Medical Group, Bronx, New York, United States

North Carolina
Gambro Healthcare-Wilson, Wilson, North Carolina, United States
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

Ohio
Kidney and Hypertension Center, Cincinnati, Ohio, 45220, United States
Ohio State University College of Pharmacy, Columbus, Ohio, United States

Pennsylvania
Albert Einstein Medical Center, Philadelphia, Pennsylvania, 19141, United States
DaVita Lewistown Dialysis Center, Lewistown, Pennsylvania, United States
FMC of Bethlehem, Allentown, Pennsylvania, United States
Fresenius Medical Care, Greensburg, Pennsylvania, United States
Hypertension and Kidney Specialists, Lancaster, Pennsylvania, United States
Nesbitt College of Pharmacy and Nursing Department of Pharmacy Practice, Wilkes-Barre, Pennsylvania, United States
P.C. & Associates, Philadelphia, Pennsylvania, United States

South Carolina
Gambro Healthcare-Aiken, Aiken, South Carolina, United States

Tennessee
Midsouth Nephrology Consultants, Memphis, Tennessee, United States

Texas
Dallas Nephrology Associates, Dallas, Texas, United States
Nephrology, Dialysis and Transplant Association, Houston, Texas, United States
San Antonio Kidney Disease Center, San Antonio, Texas, United States
West Houston Dialysis, Houston, Texas, United States

Virginia
Clinical Research of Tidewater, Norfolk, Virginia, 23507, United States
Gambro Healthcare - Charlottesville, Charlottesville, Virginia, 22902, United States
Virginia Commonwealth University, Division of Nephrology, Richmond, Virginia, 23298, United States
Clinical Research and Consulting Center, LLC, Fairfax, Virginia, United States

Washington
Vancouver Clinic Inc., P.S., Vancouver, Washington, United States

Puerto Rico
Clinical Las Americas, San Juan, Puerto Rico

More Information

US FDA Approved Full Prescribing Information for Renagel®

Study ID Numbers: GTC-68-401

ClinicalTrials.gov Identifier: NCT00324571

Health Authority: United States: Food and Drug Administration