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Clinical Trial Details

Trial ID: L0802
Source ID: NCT00441545
Associated Drug: Fosrenol (Lanthanum Carbonate)
Title: Head to Head Study Against Sevelamer Hydrochloride
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00441545/results
Conditions: Chronic Kidney Disease, Stage 5
Interventions: DRUG: Fosrenol (Lanthanum Carbonate)|DRUG: Sevelamer hydrochloride
Outcome Measures: Primary: Change From Baseline in Serum Phosphorus Levels at 4 Weeks, 4 weeks | Secondary: 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, Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous is 3.5 - 5.5 mg/dL (1.13 - 1.77 mmol/L), 4 weeks
Sponsor/Collaborators: Sponsor: Shire
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 182
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2007-01-05
Completion Date: 2008-07-31
Results First Posted: 2009-08-13
Last Update Posted: 2021-06-11
Locations: DSI Renal Inc., Mesa, Arizona, 85202, United States|AKDHC Medical Research Services, LLC, Phoenix, Arizona, 85012, United States|Southwest Kidney Institute, PLC, Tempe, Arizona, 85284, United States|Tempe, Arizona, 85284, United States|University of Arizona Health Service Center, Tucson, Arizona, 85724, United States|Clinical Research Connections, Jonesboro, Arkansas, 72401, United States|South Valley Dialysis Center, Encino, California, 91316, United States|VA Greater Los Angeles Health Care System, West LA, Los Angeles, California, 90073, United States|Apex Research of Riverside, Riverside, California, 92505, United States|North Valley Nephrology, Yuba City, California, 95991, United States|Western Nephrology & Metabolic Bone Disease, PC, Thornton, Colorado, 80260, United States|Shands University of Florida Outpatient Dialysis, Gainesville, Florida, 32608, United States|Discovery Medical Research Group, Ocala, Florida, 34471, United States|Pines Clinical Research, Pembroke Pines, Florida, 33028, United States|Clinical Research Center of Indian River Medical Center, Vero Beach, Florida, United States|Kidney Care Associates, LLC, Augusta, Georgia, 30901, United States|Renal Physicians of Georgia, Macon, Georgia, 31217, United States|Evanston Northwestern Hospital, Evanston, Illinois, 60201, United States|Research by Design, LLC, Evergreen Park, Illinois, 60805, United States|Nephrology Inc., Mishawaka, Indiana, 46545, United States|Renal Associates of Baton Rouge, Baton Rouge, Louisiana, 70809, United States|Creighton University Medical Center, Omaha, Nebraska, 68131, United States|Hypertension and Nephrology, Associates, Eatontown, New Jersey, 07724, United States|Winthrop Dialysis Center, Mineola, New York, 11501, United States|SUNY at Stony Brook NY, Stony Brook, New York, 11794, United States|Wake Nephrology Associates, Raleigh, North Carolina, 27609, United States|Southeastern Nephrology Associates, Wilmington, North Carolina, 28401, United States|Northwest Renal Clinic, Portland, Oregon, 97210, United States|Carolina Nephrology, PA, Greenville, South Carolina, 29605, United States|VA Tennessee Valley Healthcare System, Nashville, Tennessee, 37212, United States|Rosa Verde Tower, San Antonio, Texas, 78205, United States|University of Texas Health Science Center at San Antonio Medicine/Nephrology, San Antonio, Texas, 78229, United States|Alexandria Kidney, Alexandria, Virginia, 22304, United States|Clinical Research & Consulting Center, LLC, Fairfax, Virginia, 22030, United States|KfH Nierenzentrum/Bad/Konig, Bad Konig, 64732, Germany|KfH Nierenzentrum, Berlin, 10559, Germany|KfH Dialysezentrum/Berlin, Berlin, 12045, Germany|KfH Nierenzentrum/Dulmen, Dulmen, 48249, Germany|Georg-August-Universitat Universitatsmedizin Abt. Nephrologie u. Rheumatologie, Gottingen, 37075, Germany|Dialysezentrum Barmbeck, Hamburg, 22297, Germany|KfH-Nierenzentrum/Jena, Jena, 07751, Germany|KfH-Dialysezentrum/Rosenheim, Rosenheim, 83022, Germany|Jose Cangiano, MD, San Juan, 00918, Puerto Rico|Churchill Hospital Oxford Kidney Unit, Oxford, OX3 7LJ, United Kingdom
URL: https://clinicaltrials.gov/show/NCT00441545

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress