Dialysis Clinical Outcomes Revisited (DCOR) Trial
This study has been completed.
Sponsor:
Genzyme
Information provided by:
Genzyme
ClinicalTrials.gov Identifier:
NCT00324571
First received: May 9, 2006
Last updated: July 29, 2009
Last verified: May 2006
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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:
Drug Information available for:
Calcium Gluconate
Sevelamer
Sevelamer hydrochloride
Sevelamer carbonate
U.S. FDA Resources
Further study details as provided by Genzyme:
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00324571
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Hide Study LocationsLocations
| 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
Investigators
| Study Director: | Medical Monitor | Genzyme |
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 May 19, 2013