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Clinical Trial Details

Trial ID: L1500
Source ID: NCT00704483
Associated Drug: Sbr759
Title: Efficacy of SBR759 in Lowering Serum Phosphate Levels in Chronic Kidney Disease Patients on Hemodialysis
Acronym: SBR759
Status: COMPLETED
Study Results: NO
Results:
Conditions: Hyperphosphatemia Patients With Chronic Kidney Disease on 3x/Week Replacement Therapy
Interventions: DRUG: SBR759|DRUG: Sevelamer HCl|DRUG: SBR759|DRUG: Sevelamer HCl
Outcome Measures: Primary: Responder rates in target serum phosphate levels at 12 weeks Evaluate efficacy of SBR759 compared to sevelamer HCl at 12 weeks, Time Frame: 12 weeks + 12 months | Secondary: Responder rates in target patients with serum calcium-phosphate levels at 12 weeks/12 months, Time Frame: 12 weeks / 12 months
Sponsor/Collaborators: Sponsor: Novartis Pharmaceuticals
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 321
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2008-07
Completion Date:
Results First Posted:
Last Update Posted: 2020-12-19
Locations: Novartis, Chula Vista, California, 91910, United States|Novartis, La Mesa, California, 91942, United States|Novartis, Whittier, California, 90602, United States|Novartis, Denver, Colorado, 80262, United States|Novartis, North Chicago, Illinois, 60064, United States|Novartis, Peoria, Illinois, 61602, United States|Novartis, Mishawaka, Indiana, 46545, United States|Novartis, Baltimore, Maryland, 21287, United States|Novartis, Fall River, Massachusetts, 02720, United States|Novartis, Springfield, Massachusetts, 01104, United States|Novartis Investigative Site, Omaha, Nebraska, 68144, United States|Novartis, New York, New York, 10032, United States|Novartis, Winston-Salem, North Carolina, 27157-1082, United States|Novarits, Fargo, North Dakota, 58103, United States|Novartis, Portland, Oregon, 97210, United States|Novartis, Pittsburgh, Pennsylvania, 15224, United States|Novartis Investigative Site, Houston, Texas, 77024, United States|Novartis, San Antonio, Texas, 78207, United States|Novartis, Fairfax, Virginia, 22031, United States|Novartis, Adelaide, South Australia, Australia|Novartis, Fitzroy, Victoria, Australia|Novartis, Parkville, Victoria, 3052, Australia|Novartis, Melbourne, 3065, Australia|Novartis, South Brisbane, Australia|Novartis, Woolloongabba, 4102, Australia|Novartis Investigative Site, Antwerpen, Belgium|Novartis, Brugge, 8000, Belgium|Novartis, Bruxelles, 1000, Belgium|Novartis, Liege, 4000, Belgium|Novartis Investigative Site, Saint Niklaas, Belgium|Novartis Investigative Site, Edmonton, Canada|Novartis Investigative Site, London, Canada|Novartis Investigative Site, Oshawa, Canada|Novartis Investigative Site, Quebec, Canada|Novartis, Helsinki, 00100, Finland|Novartis, Oulu, 90100, Finland|Novartis, Tampere, 33100, Finland|Novartis, Turku, 20100, Finland|Novartis, Amiens, 80054, France|Novartis, Fleury Merogis, France|Novartis, Lyon Cedex, 69446, France|Novartis, Rheims Cedex, 51685, France|Novartis, Salouel, 80480, France|Novartis Investigative Site, Berlin, Germany|Novartis Investigative Site, Coburg, Germany|Novartis Investigative Site, Lecco, Italy|Novartis Investigative Site, Lodi, Italy|Novartis Investigative Site, Milano, Italy|Novartis Investigative Site, Modena, Italy|Novartis Investigative Site, Pavia, Italy|Novartis, Bergen, 5011, Norway|Novartis, Kristiansand, 1001, Norway|Novartis, Oslo, 0027, Norway|Novartis, Tonsberg, Norway|Novartis, San Juan, 00927, Puerto Rico|Novartis Investigative Site, Jonkoping, Sweden|Novartis Investigative Site, Karlstad, Sweden|Novartis Investigative Site, Skovde, Sweden|Novartis Investigative Site, Stockholm, Sweden|Novartis, Aarau, 5000, Switzerland|Novartis, Lausanne, 1011, Switzerland|Novartis, Zurich, 8091, Switzerland|Novartis, Hull, United Kingdom|Novartis Investigative Site, Manchester, United Kingdom|Novartis Investigative Site, Portsmouth, United Kingdom|Novartis, Salford, United Kingdom
URL: https://clinicaltrials.gov/show/NCT00704483