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Clinical Trial Details

Trial ID: L0532
Source ID: NCT00681941
Associated Drug: Sevelamer Carbonate (Renvela®)
Title: An Open Label Dose Titration of Sevelamer Carbonate Tabs 3 Times a Day in Hyperphosphatemic CKD Patients Not On Dialysis
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Chronic Kidney Disease|Hyperphosphatemia
Interventions: DRUG: Sevelamer carbonate (Renvela®)
Outcome Measures: Primary: Evaluate the efficacy of sevelamer carbonate tablets dosed three times per day (TID) with meals on control of serum phosphorus levels, Up to day 70|Evaluate the safety and tolerability of sevelamer carbonate tablets dosed TID with meals., Up to day 70 | Secondary: Serum calcium-phosphorus product, Up to day 70|Serum lipid profile [total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol], Up to day 70|Percent responders [serum phosphorus between 2.7 and 4.6 mg/dL (0.87 and 1.49 mmol/L) inclusive] at Day 56/ET, Up to day 70
Sponsor/Collaborators: Sponsor: Genzyme, a Sanofi Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 49
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2006-01
Completion Date: 2007-03
Results First Posted:
Last Update Posted: 2015-03-20
Locations: Nephrology Department, Princess Alexandra Hospital, Wooloongabba, Queensland, 4102, Australia|Renal Unit, The Queen Elizabeth Hospital, Woodville, South Australia, 5011, Australia|Renal Research Unit, Launceston General Hospital, Launceston, Tasmania, 7250, Australia|The Royal Melbourne Hospital, Department of Nephrology, Parkville, Victoria, 3050, Australia|Melbourne Renal Research Group, Epworth Medical Centre, Richmond, Victoria, 3121, Australia|Nyremedicinsk Afdeling, Medicinerhuset, Aalborg, DK-9100, Denmark|Nefrologisk Afdeling, Hilleroed Sygehus, Hilleroed, DK 3400, Denmark|Medicinsk Afdeling, København, DK-2100, Denmark|Medicinsk Afdeling, nefrologisk, Roskilde Sygehus, Roskilde, DK-4000, Denmark|George Pompidou, European Hospital, Paris, 75908, France|Universitätsklinikum Aachen, Medizinsche Klinik II, Aachen, D-52074, Germany|Universitätsklinikum Hamburg Eppendorf, Hamburg, D-20246, Germany|Heimdialysezentrum, Heidelberg, D-69115, Germany|KfH Nierenzentrum, Nürnberg, D-90431, Germany|Stadt Klinken Solingen, Klinik für Nephrologie und Allgemeine Innere Medizin, Solingen, D 42653, Germany|Nephrologisches Zentrum, Villingen-Schwenningen, D 78054, Germany|Birmingham Hospital, Queen Elizabeth Medical Centre, Birmingham, England, B15 2PR, United Kingdom|Southmead Hospital, Bristol, England, BS10 5NB, United Kingdom|Addenbrooke's Dialysis Centre, Cambridge, England, CB2 2QQ, United Kingdom|Leicester General Hospital, Leicester, England, LE5 4PW, United Kingdom|Renal Department, The Royal London Hospital, London, England, E1 1BB, United Kingdom|Renal & Urology SDU Offices, London, England, SE1 9RT, United Kingdom|Renal Dialysis Unit, Manchester Royal Infirmary, Manchester, England, M13 9WL, United Kingdom|Department of Renal Medicine, Hope Hospital, Manchester, England, M6 8HD, United Kingdom|Renal Unit, Queen Alexandra Hospital, Portsmouth, England, PO6 3RY, United Kingdom
URL: https://clinicaltrials.gov/show/NCT00681941

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress