Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
2000 participants
INTERVENTIONAL
2001-03-31
2006-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Sevelamer hydrochloride
Calcium-based phosphate binder
Eligibility Criteria
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Inclusion Criteria
* on dialysis for more than 3 months,
* require phosphate binder therapy,
* have Medicare as their primary insurance.
Exclusion Criteria
* swallowing disorders,
* severe gastrointestinal motility disorders,
* bowel obstruction.
18 Years
ALL
No
Sponsors
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Genzyme, a Sanofi Company
INDUSTRY
Responsible Party
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Genzyme Corporation
Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Genzyme, a Sanofi Company
Locations
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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, 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, 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, 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, United States
Clinical Research and Consulting Center, LLC
Fairfax, Virginia, United States
Clinical Research of Tidewater
Norfolk, Virginia, United States
Virginia Commonwealth University, Division of Nephrology
Richmond, Virginia, United States
Vancouver Clinic Inc., P.S.
Vancouver, Washington, United States
Clinical Las Americas
San Juan, , Puerto Rico
Countries
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References
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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.
Other Identifiers
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GTC-68-401
Identifier Type: -
Identifier Source: org_study_id
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