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Clinical Trial Details

Trial ID: L0678
Source ID: NCT00268957
Associated Drug: Sevelamer Carbonate (Renvela®)
Title: Study to Compare Sevelamer Carbonate Powder to Sevelamer Hydrochloride Tablets in Patients With CKD on Hemodialysis
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Kidney Diseases|Chronic Renal Insufficiency|End-Stage Renal Disease
Interventions: DRUG: Sevelamer carbonate (Renvela®)|DRUG: Sevelamer hydrochloride (Renagel®)
Outcome Measures: Primary: Demonstrate the efficacy of sevelamer carbonate powder dosed QD with the largest meal to sevelamer hydrochloride tablets dosed TID with meals on the control of serum phosphorus, Up to 24 weeks|Evaluate the safety and tolerability of sevelamer carbonate powder dosed QD with the largest meal compared to sevelamer hydrochloride tablets dosed TID with meals, Up to 24 weeks | Secondary: Compare sevelamer carbonate powder dosed QD with the largest meal to sevelamer hydrochloride tablets TID with meals on serum calcium-phosphorus product and serum lipid profile, Up to 24 weeks
Sponsor/Collaborators: Sponsor: Genzyme, a Sanofi Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 217
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2006-01
Completion Date: 2007-05
Results First Posted:
Last Update Posted: 2014-03-19
Locations: Clinical Research Center, Birmingham, Alabama, 35213, United States|Gadsden Dialysis, Gadsden, Alabama, 35901, United States|Holy Cross Renal Care, Mission Hills, California, 91345, United States|Nephrology Educational Services and Research, Tarzana, California, 91356, United States|Crystal Rivers Dialysis Center, Crystal River, Florida, 34429, United States|Outcomes Research International, Inc., Hudson, Florida, 34667, United States|Central Dialysis Center, Atlanta, Georgia, 30329, United States|Atlanta Nephrology Referral Center, Decatur, Georgia, 30030, United States|FMC Marietta, Marietta, Georgia, 30066, United States|Horizon Healthcare Associates, Flossmoor, Illinois, 60422, United States|Indiana University Hospital, Indianapolis, Indiana, 46202, United States|Ochsner Clinic Foundation, Nephrology Research, New Orleans, Louisiana, 70121, United States|Henry Ford Hospital, Detroit, Michigan, 48202, United States|Southwest Mississippi Nephrology, PLLC, Brookhaven, Mississippi, 39601, United States|Nephrology Associates, P.C., Columbus, Mississippi, 39705, United States|Nephrology & Hypertension Associates, LTD, Tupelo, Mississippi, 38801, United States|Washington University School of Medicine, St. Louis, Missouri, 63110, United States|Hypertension and Nephrology Associates, Eatontown, New Jersey, 07724, United States|Davita, Bronx, New York, 10461, United States|Winthrop University Dialysis Center, Mineola, New York, 11501, United States|Kidney and Hypertension Center, Cincinnati, Ohio, 45220, United States|Renal Care Group, Cleveland, Ohio, 44109, United States|Lewiston Dialysis Center, Lewistown, Pennsylvania, 17044, United States|Medical Nephrology Associates, Dyersburg, Tennessee, 38024, United States|Nephrology Associates, P.C., Nashville, Tennessee, 37205, United States|Renal Research Inc. at the Kidney Institute, Houston, Texas, 77054, United States|Gambro Healthcare - Charlottesville, Charlottesville, Virginia, 22902, United States|Clinical Research of Tidewater, Norfolk, Virginia, 23507, United States|Virginia Commonwealth University, Division of Nephrology, Richmond, Virginia, 23298, United States
URL: https://clinicaltrials.gov/show/NCT00268957

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress