Dialysis Clinical Outcomes Revisited (DCOR) Trial
- Conditions
- Chronic Kidney Disease
- Registration Number
- NCT00324571
- Lead Sponsor
- Genzyme, a Sanofi Company
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2000
- 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.
- dysphagia,
- swallowing disorders,
- severe gastrointestinal motility disorders,
- bowel obstruction.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Safety will be assessed based on an evaluation of related serious adverse events. 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (70)
nTouch Research
🇺🇸Raleigh, North Carolina, United States
Gambro Healthcare-Hartford
🇺🇸Hartford, Connecticut, United States
Nephrology Associates, P.C.
🇺🇸Columbus, Mississippi, United States
Gambro Healthcare-Plantation
🇺🇸Plantation, Florida, United States
Dublin Nephrology
🇺🇸Dublin, Georgia, United States
Gambro Healthcare-Americus
🇺🇸Americus, Georgia, United States
Pensacola Nephrology, P.A.
🇺🇸Pensacola, Florida, United States
Palomar Medical Group
🇺🇸Escondido, California, United States
Renal Care Associates, S.C.
🇺🇸Peoria, Illinois, United States
Gambro Healthcare-Aiken
🇺🇸Aiken, South Carolina, United States
Ohio State University College of Pharmacy
🇺🇸Columbus, Ohio, United States
Nephrology, Dialysis and Transplant Association
🇺🇸Houston, Texas, United States
Nephrology Associates
🇺🇸New Britain, Connecticut, United States
InterAmerican Dialysis
🇺🇸Coral Gables, Florida, United States
DaVita Crystal River Dialysis
🇺🇸Crystal River, Florida, United States
Gambro Healthcare-Douglas
🇺🇸Douglas, Georgia, United States
Georgia Kidney Associates, Inc.
🇺🇸Marietta, Georgia, United States
Northwest Louisiana Nephrology, LLC.
🇺🇸Shreveport, Louisiana, United States
Gambro Healthcare-Frederick
🇺🇸Frederick, Maryland, United States
Associates in Nephrology, P.C.
🇺🇸Brockton, Massachusetts, United States
Western New England Renal and Transplant Associates, Inc.
🇺🇸Springfield, Massachusetts, United States
Gambro Healthcare-Gadsden
🇺🇸Gadsden, Alabama, United States
Gambro Healthcare
🇺🇸El Cerrito, California, United States
Gambro Healthcare-Los Angeles
🇺🇸Los Angeles, California, United States
Nephrology Educational Services and Research
🇺🇸Tarzana, California, United States
Balboa Nephrology Medical Group
🇺🇸San Diego, California, United States
Gambro Healthcare-Douglasville
🇺🇸Douglasville, Georgia, United States
Gambro Healthcare-Rome
🇺🇸Rome, Georgia, United States
Gambro Healthcare-Savannah
🇺🇸Savannah, Georgia, United States
MacNeal Renal Lifeline Services
🇺🇸Berwyn, Illinois, United States
Gambro Healthcare-Springfield Central
🇺🇸Springfield, Illinois, United States
Horizon Healthcare Associates
🇺🇸Olympia Fields, Illinois, United States
Southwest Nephrology
🇺🇸Evergreen Park, Illinois, United States
Lincolnland Dialysis
🇺🇸Springfield, Illinois, United States
Nephrology Specialists, PC.
🇺🇸Valparaiso, Indiana, United States
DaVita Crystal City Dialysis
🇺🇸St. Louis, Missouri, United States
Bronx Westchester Medical Group
🇺🇸Bronx, New York, United States
Wake Nephrology/Wake Dialysis Clinic
🇺🇸Raleigh, North Carolina, United States
Mountain Kidney Associates, P.A.
🇺🇸Asheville, North Carolina, United States
Gambro Healthcare-Wilson
🇺🇸Wilson, North Carolina, United States
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
P.C. & Associates
🇺🇸Philadelphia, Pennsylvania, United States
Nesbitt College of Pharmacy and Nursing Department of Pharmacy Practice
🇺🇸Wilkes-Barre, Pennsylvania, United States
Gambro Healthcare - Charlottesville
🇺🇸Charlottesville, Virginia, United States
Clinical Research of Tidewater
🇺🇸Norfolk, Virginia, United States
Clinical Research and Consulting Center, LLC
🇺🇸Fairfax, Virginia, United States
Dallas Nephrology Associates
🇺🇸Dallas, Texas, United States
West Houston Dialysis
🇺🇸Houston, Texas, United States
Vancouver Clinic Inc., P.S.
🇺🇸Vancouver, Washington, United States
Wichita Nephrology
🇺🇸Wichita, Kansas, United States
Wichita Dialysis Center East
🇺🇸Wichita, Kansas, United States
San Antonio Kidney Disease Center
🇺🇸San Antonio, Texas, United States
Gambro Healthcare-Miami
🇺🇸Miami, Florida, United States
Lowry Dialysis Center
🇺🇸Denver, Colorado, United States
Miami Kidney Group
🇺🇸Miami, Florida, United States
DaVita Clinical Research
🇺🇸Minneapolis, Minnesota, United States
Genesis Clinical Research Corp
🇺🇸Tampa, Florida, United States
Kidney and Hypertension Center
🇺🇸Cincinnati, Ohio, United States
Nephrology and Endocrine Associates
🇺🇸Las Vegas, Nevada, United States
University of Missouri-Kansas City
🇺🇸Kansas City, Missouri, United States
BMA of Washington
🇺🇸Bethesda, Maryland, United States
Kidney Health Institute, LLC
🇺🇸Tucson, Arizona, United States
America Dialysis
🇺🇸St. Petersburg, Florida, United States
Clinical Las Americas
🇵🇷San Juan, Puerto Rico
Midsouth Nephrology Consultants
🇺🇸Memphis, Tennessee, United States
Virginia Commonwealth University, Division of Nephrology
🇺🇸Richmond, Virginia, United States