Therapeutic Equivalence of OsvaRen® Tablets and OsvaRen® Granules
NCT02027662 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 61
Last updated 2015-06-10
Summary
Phosphate binders are crucial to the control of elevated phosphate levels in patients with chronic kidney disease. With the new formulation of granules the pill burden of patients is sought to be reduced.
This study is about efficacy and safety of the new drug formulation and compares it to the "old" formulation which are film-coated tablets.
Conditions
- Hyperphosphatemia
- Chronic Kidney Disease
Interventions
- DRUG
-
Osvaren Granules
- DRUG
-
Osvaren film-coated tablets
Sponsors & Collaborators
-
Fresenius Medical Care Deutschland GmbH
lead INDUSTRY
Principal Investigators
-
Jürgen Floege, MD · University Aachen
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-01-31
- Primary Completion
- 2015-04-30
- Completion
- 2015-06-30
Countries
- Germany
Study Locations
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