- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00324571
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
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
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San Juan, Puerto Rico
- Clinical Las Americas
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Alabama
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Gadsden, Alabama, United States
- Gambro Healthcare-Gadsden
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Huntsville, Alabama, United States
- nTouch Research
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Arizona
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Tucson, Arizona, United States
- Kidney Health Institute, LLC
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California
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El Cerrito, California, United States
- Gambro Healthcare
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Escondido, California, United States
- Palomar Medical Group
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Los Angeles, California, United States
- Gambro Healthcare-Los Angeles
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San Diego, California, United States
- Balboa Nephrology Medical Group
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Tarzana, California, United States
- Nephrology Educational Services and Research
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Colorado
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Denver, Colorado, United States
- Lowry Dialysis Center
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Connecticut
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Bridgeport, Connecticut, United States
- Nephrology Associates, P.C.
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Hartford, Connecticut, United States
- Gambro Healthcare-Hartford
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New Britain, Connecticut, United States
- Nephrology Associates
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Florida
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Coral Gables, Florida, United States
- InterAmerican Dialysis
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Crystal River, Florida, United States
- DaVita Crystal River Dialysis
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Miami, Florida, United States
- Gambro Healthcare-Miami
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Miami, Florida, United States
- Miami Kidney Group
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Pensacola, Florida, United States
- Pensacola Nephrology, P.A.
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Plantation, Florida, United States
- Gambro Healthcare-Plantation
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St. Petersburg, Florida, United States
- America Dialysis
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Tampa, Florida, United States
- Genesis Clinical Research Corp
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Georgia
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Americus, Georgia, United States
- Gambro Healthcare-Americus
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Atlanta, Georgia, United States
- nTouch Research
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Douglas, Georgia, United States
- Gambro Healthcare-Douglas
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Douglasville, Georgia, United States
- Gambro Healthcare-Douglasville
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Dublin, Georgia, United States
- Dublin Nephrology
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Marietta, Georgia, United States
- Georgia Kidney Associates, Inc.
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Rome, Georgia, United States
- Gambro Healthcare-Rome
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Savannah, Georgia, United States
- Gambro Healthcare-Savannah
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Illinois
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Berwyn, Illinois, United States
- MacNeal Renal Lifeline Services
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Evergreen Park, Illinois, United States
- Southwest Nephrology
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Olympia Fields, Illinois, United States
- Horizon Healthcare Associates
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Peoria, Illinois, United States
- Renal Care Associates, S.C.
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Springfield, Illinois, United States
- Gambro Healthcare-Springfield Central
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Springfield, Illinois, United States
- Lincolnland Dialysis
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Indiana
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Valparaiso, Indiana, United States
- Nephrology Specialists, PC.
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Kansas
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Wichita, Kansas, United States
- Wichita Dialysis Center East
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Wichita, Kansas, United States
- Wichita Nephrology
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Louisiana
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Shreveport, Louisiana, United States
- Northwest Louisiana Nephrology, LLC.
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Maryland
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Bethesda, Maryland, United States
- BMA of Washington
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Frederick, Maryland, United States
- Gambro Healthcare-Frederick
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Massachusetts
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Brockton, Massachusetts, United States
- Associates in Nephrology, P.C.
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Springfield, Massachusetts, United States
- Western New England Renal and Transplant Associates, Inc.
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Minnesota
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Minneapolis, Minnesota, United States
- Davita Clinical Research
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Mississippi
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Columbus, Mississippi, United States, 39705
- Nephrology Associates, P.C.
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Missouri
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Kansas City, Missouri, United States
- University of Missouri-Kansas City
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St. Louis, Missouri, United States
- DaVita Crystal City Dialysis
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Nevada
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Las Vegas, Nevada, United States
- Nephrology and Endocrine Associates
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New York
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Bronx, New York, United States
- Bronx Westchester Medical Group
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North Carolina
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Asheville, North Carolina, United States
- Mountain Kidney Associates, P.A.
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Raleigh, North Carolina, United States
- nTouch Research
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Raleigh, North Carolina, United States
- Wake Nephrology/Wake Dialysis Clinic
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Wilson, North Carolina, United States
- Gambro Healthcare-Wilson
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Ohio
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Cincinnati, Ohio, United States, 45220
- Kidney and Hypertension Center
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Columbus, Ohio, United States
- Ohio State University College of Pharmacy
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Pennsylvania
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Allentown, Pennsylvania, United States
- FMC of Bethlehem
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Greensburg, Pennsylvania, United States
- Fresenius Medical Care
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Lancaster, Pennsylvania, United States
- Hypertension and Kidney Specialists
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Lewistown, Pennsylvania, United States
- DaVita Lewistown Dialysis Center
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Philadelphia, Pennsylvania, United States, 19141
- Albert Einstein Medical Center
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Philadelphia, Pennsylvania, United States
- P.C. & Associates
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Wilkes-Barre, Pennsylvania, United States
- Nesbitt College of Pharmacy and Nursing Department of Pharmacy Practice
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South Carolina
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Aiken, South Carolina, United States
- Gambro Healthcare-Aiken
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Tennessee
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Memphis, Tennessee, United States
- Midsouth Nephrology Consultants
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Texas
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Dallas, Texas, United States
- Dallas Nephrology Associates
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Houston, Texas, United States
- Nephrology, Dialysis and Transplant Association
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Houston, Texas, United States
- West Houston Dialysis
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San Antonio, Texas, United States
- San Antonio Kidney Disease Center
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Virginia
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Charlottesville, Virginia, United States, 22902
- Gambro Healthcare - Charlottesville
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Fairfax, Virginia, United States
- Clinical Research and Consulting Center, LLC
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Norfolk, Virginia, United States, 23507
- Clinical Research of Tidewater
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Richmond, Virginia, United States, 23298
- Virginia Commonwealth University, Division of Nephrology
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Washington
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Vancouver, Washington, United States
- Vancouver Clinic Inc., P.S.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
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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.
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Safety will be assessed based on an evaluation of related serious adverse events.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GTC-68-401
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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