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Clinical Trial Details

Trial ID: L0926
Source ID: NCT00196755
Associated Drug: Sevelamer Hydrochloride (Renagel®)
Title: Study of Safety and Efficacy of Renagel® Compared With Calcium Acetate in Patients With Peritoneal Dialysis
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Peritoneal Dialysis|Chronic Kidney Disease
Interventions: DRUG: Sevelamer Hydrochloride (Renagel®)|DRUG: Calcium acetate (PhosLo® )
Outcome Measures: Primary: Compare the effects of sevelamer dosed three times per day (TID) and calcium acetate dosed TID on serum phosphorus., 12 weeks | Secondary: Serum calcium- phosphorus (CaxPO4) product, 12 weeks|Serum lipids - total and LDL cholesterol, non- HDL cholesterol, HDL, triglycerides, 12 weeks|Plasma biomarkers: random blood glucose, glycosylated haemoglobin, bone specific alkaline phosphatase, uric acid and c-reactive protein, 12 weeks
Sponsor/Collaborators: Sponsor: Genzyme, a Sanofi Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 138
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2004-12
Completion Date: 2006-04
Results First Posted:
Last Update Posted: 2015-03-18
Locations: UZ Gasthuisberg, Leuven, B-3000, Belgium|Fredericia Sygehus, Fredericia, DN-7000, Denmark|Copenhagen University Hospital, Herlev, DN-2730, Denmark|Aarhus University Hospital, Århus N, DN-8200, Denmark|CHRU Clémenceau, Caen, FR-14033, France|Ospedale civico e benfratelli, Palermo, IT-90127, Italy|Ospedale San Bortolo, Vicenza, IT-36100, Italy|AMC, Amsterdam, NL-1105 AZ, Netherlands|Fundacion Jimenez Diaz, Madrid, ES-28040, Spain|Hospital Universitario La Paz, Madrid, ES-28046, Spain|University Hospital ,Queen Elizabeth Hospital, Birmingham, B15 2TH, United Kingdom|High Wycombe Hospital, Buckinghamshire, HP11 2TT, United Kingdom|University of Wales College of Medicine, Cardiff, CF 14 4XN, United Kingdom|Glasgow Western Infirmary, Glasgow, G11 6NT, United Kingdom|Royal Hospital The Royal London, London, E1 1BB, United Kingdom|Milton Keynes General Hospital, Milton Keynes, MK6 5LD, United Kingdom|The Churchill Hospital, Oxford Radcliffe Hospitals NHS Trust, Oxford, OX3 7LJ, United Kingdom
URL: https://clinicaltrials.gov/show/NCT00196755

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress