Efficacy of SBR759 in Lowering Serum Phosphate Levels in Chronic Kidney Disease Patients on Hemodialysis
NCT00704483 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 321
Last updated 2020-12-19
Summary
This study will evaluate the efficacy of SBR759 compared to sevelamer HCl in lowering serum phosphate levels in Chronic Kidney Disease patients on hemodialysis
Conditions
- Hyperphosphatemia Patients With Chronic Kidney Disease on 3x/Week Replacement Therapy
Interventions
- DRUG
-
SBR759
Starting dose of 1g or 1.5g tid, with an increase of 1g tid every 2 weeks until serum phosphate level fall below target.
- DRUG
-
Sevelamer HCl
0.8 g tid
- DRUG
-
SBR759
1.5 g tid
- DRUG
-
Sevelamer HCl
1.6 g tid
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis · Novartis
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-07-31
- Primary Completion
- 2010-08-31
Countries
- United States
- Australia
- Belgium
- Canada
- Finland
- France
- Germany
- Italy
- Norway
- Puerto Rico
- Sweden
- Switzerland
- United Kingdom
Study Locations
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