Chronic Kidney Disease Clinical Trial
Official title:
Study to Investigate Efficacy and Safety Equivalence of OsvaRen® Tablets and OsvaRen® Granules
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
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