Head to Head Study Against Sevelamer Hydrochloride
- Conditions
- Chronic Kidney Disease, Stage 5
- Interventions
- Registration Number
- NCT00441545
- Lead Sponsor
- Shire
- Brief Summary
To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.
- Detailed Description
To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 182
- Adults with end stage renal disease who are receiving dialysis
- Subjects with significant gastrointestinal disorders
- Subjects who are pregnant or nursing
- Subjects currently taking lanthanum carbonate, sevelamer hydrochloride, cinacalcet hydrochloride
- Subjects who are HIV positive
- Subjects with clinical significant liver disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 Fosrenol (Lanthanum Carbonate) Fosrenol (Lanthanum carbonate) 2 Sevelamer hydrochloride Sevelamer hydrochloride
- Primary Outcome Measures
Name Time Method Change From Baseline in Serum Phosphorus Levels at 4 Weeks 4 weeks
- Secondary Outcome Measures
Name Time Method Change From Baseline in Serum Calcium Levels at 4 Weeks 4 weeks Levels of Intact Parathyroid Hormone (iPTH) at Baseline and 4 Weeks Baseline and 4 weeks Patients Achieving Kidney Disease Outcomes Quality Initiative (KDOQI) Target for Serum Phosphorous at 4 Weeks 4 weeks Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous is 3.5 - 5.5 mg/dL (1.13 - 1.77 mmol/L)
Trial Locations
- Locations (43)
Apex Research of Riverside
🇺🇸Riverside, California, United States
VA Greater Los Angeles Health Care System, West LA
🇺🇸Los Angeles, California, United States
Rosa Verde Tower
🇺🇸San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio Medicine/Nephrology
🇺🇸San Antonio, Texas, United States
VA Tennessee Valley Healthcare System
🇺🇸Nashville, Tennessee, United States
Clinical Research Connections
🇺🇸Jonesboro, Arkansas, United States
Jose Cangiano, MD
🇵🇷San Juan, Puerto Rico
Renal Associates of Baton Rouge
🇺🇸Baton Rouge, Louisiana, United States
Hypertension and Nephrology, Associates
🇺🇸Eatontown, New Jersey, United States
DSI Renal Inc.
🇺🇸Mesa, Arizona, United States
Southwest Kidney Institute, PLC
🇺🇸Tempe, Arizona, United States
University of Arizona Health Service Center
🇺🇸Tucson, Arizona, United States
South Valley Dialysis Center
🇺🇸Encino, California, United States
Western Nephrology & Metabolic Bone Disease, PC
🇺🇸Thornton, Colorado, United States
Discovery Medical Research Group
🇺🇸Ocala, Florida, United States
North Valley Nephrology
🇺🇸Yuba City, California, United States
Clinical Research Center of Indian River Medical Center
🇺🇸Vero Beach, Florida, United States
Kidney Care Associates, LLC
🇺🇸Augusta, Georgia, United States
Pines Clinical Research
🇺🇸Pembroke Pines, Florida, United States
Evanston Northwestern Hospital
🇺🇸Evanston, Illinois, United States
Renal Physicians of Georgia
🇺🇸Macon, Georgia, United States
Research by Design, LLC
🇺🇸Evergreen Park, Illinois, United States
Nephrology Inc.
🇺🇸Mishawaka, Indiana, United States
Winthrop Dialysis Center
🇺🇸Mineola, New York, United States
SUNY at Stony Brook NY
🇺🇸Stony Brook, New York, United States
Wake Nephrology Associates
🇺🇸Raleigh, North Carolina, United States
Southeastern Nephrology Associates
🇺🇸Wilmington, North Carolina, United States
Carolina Nephrology, PA
🇺🇸Greenville, South Carolina, United States
KfH Nierenzentrum/Bad/Konig
🇩🇪Bad Konig, Germany
Alexandria Kidney
🇺🇸Alexandria, Virginia, United States
Clinical Research & Consulting Center, LLC
🇺🇸Fairfax, Virginia, United States
KfH Nierenzentrum
🇩🇪Berlin, Germany
KfH Dialysezentrum/Berlin
🇩🇪Berlin, Germany
KfH Nierenzentrum/Dulmen
🇩🇪Dulmen, Germany
Georg-August-Universitat Universitatsmedizin Abt. Nephrologie u. Rheumatologie
🇩🇪Gottingen, Germany
Dialysezentrum Barmbeck
🇩🇪Hamburg, Germany
KfH-Dialysezentrum/Rosenheim
🇩🇪Rosenheim, Germany
KfH-Nierenzentrum/Jena
🇩🇪Jena, Germany
Churchill Hospital Oxford Kidney Unit
🇬🇧Oxford, United Kingdom
Northwest Renal Clinic
🇺🇸Portland, Oregon, United States
AKDHC Medical Research Services, LLC
🇺🇸Phoenix, Arizona, United States
Creighton University Medical Center
🇺🇸Omaha, Nebraska, United States
Shands University of Florida Outpatient Dialysis
🇺🇸Gainesville, Florida, United States