Dialysis Clinical Outcomes Revisited (DCOR) Trial
A Randomized, Open Label, Parallel Design Study of Renagel® Phosphate Binder Versus Calcium-Based Phosphate Binders in Hemodialysis Patients
1 other identifier
interventional
2,000
2 countries
73
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2001
Longer than P75 for phase_4
73 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 9, 2006
CompletedFirst Posted
Study publicly available on registry
May 11, 2006
CompletedMarch 18, 2015
March 1, 2015
May 9, 2006
March 17, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- dysphagia,
- swallowing disorders,
- severe gastrointestinal motility disorders,
- bowel obstruction.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (73)
Gambro Healthcare-Gadsden
Gadsden, Alabama, United States
nTouch Research
Huntsville, Alabama, United States
Kidney Health Institute, LLC
Tucson, Arizona, United States
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
Lowry Dialysis Center
Denver, Colorado, United States
Nephrology Associates, P.C.
Bridgeport, Connecticut, United States
Gambro Healthcare-Hartford
Hartford, Connecticut, 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-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
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
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
Gambro Healthcare-Springfield Central
Springfield, Illinois, United States
Lincolnland Dialysis
Springfield, Illinois, United States
Nephrology Specialists, PC.
Valparaiso, Indiana, United States
Wichita Dialysis Center East
Wichita, Kansas, United States
Wichita Nephrology
Wichita, Kansas, United States
Northwest Louisiana Nephrology, LLC.
Shreveport, Louisiana, United States
BMA of Washington
Bethesda, Maryland, 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
DaVita Clinical Research
Minneapolis, Minnesota, United States
Nephrology Associates, P.C.
Columbus, Mississippi, 39705, United States
University of Missouri-Kansas City
Kansas City, Missouri, United States
DaVita Crystal City Dialysis
St Louis, Missouri, United States
Nephrology and Endocrine Associates
Las Vegas, Nevada, United States
Bronx Westchester Medical Group
The Bronx, New York, 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
Gambro Healthcare-Wilson
Wilson, North Carolina, United States
Kidney and Hypertension Center
Cincinnati, Ohio, 45220, United States
Ohio State University College of Pharmacy
Columbus, Ohio, 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, 19141, 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-Aiken
Aiken, South Carolina, United States
Midsouth Nephrology Consultants
Memphis, Tennessee, United States
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
Gambro Healthcare - Charlottesville
Charlottesville, Virginia, 22902, United States
Clinical Research and Consulting Center, LLC
Fairfax, Virginia, United States
Clinical Research of Tidewater
Norfolk, Virginia, 23507, United States
Virginia Commonwealth University, Division of Nephrology
Richmond, Virginia, 23298, United States
Vancouver Clinic Inc., P.S.
Vancouver, Washington, United States
Clinical Las Americas
San Juan, Puerto Rico
Related Publications (1)
Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
PMID: 40576086DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Genzyme, a Sanofi Company
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 9, 2006
First Posted
May 11, 2006
Study Start
March 1, 2001
Study Completion
February 1, 2006
Last Updated
March 18, 2015
Record last verified: 2015-03