NCT02027662

Therapeutic Equivalence of OsvaRen® Tablets and OsvaRen® Granules

Study to Investigate Efficacy and Safety Equivalence of OsvaRen® Tablets and OsvaRen® Granules

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Fresenius Medical Care Deutschland GmbH · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study is aimed at demonstrating the therapeutic equivalence of both products, i.e. granules versus tablets. Secondary objectives are: Comparing both preparations with regard to the number of patients reaching serum phosphate levels \< 1.76 mmol/L and the difference in serum phosphate levels between the first and last visit under each treatment. Furthermore, it is the aim of this study to evaluate the safety profile of OsvaRen® granules in comparison to OsvaRen® tablets. Especially serum calcium, magnesium, and PTH are of interest.

Conditions

• Hyperphosphatemia
• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	Osvaren Granules
DRUG	Osvaren film-coated tablets

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-04-01
• Completion: 2015-06-01
• First posted: 2014-01-06
• Last updated: 2015-06-10

Locations

11 sites across 1 country: Germany