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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
61
Georg-Haas-Dialysezentrum der PHV
Giessen, Hesse, Germany
RWTH University Hospital, Dpt for Nephrology
Aachen, North Rhine-Westphalia, Germany
Nephro-Studien GbR am Klinikum Erfurt
Erfurt, Germany
Dialysezentrum
Non-inferiority of phosphate control by granules versus tablets. Serum phosphate levels will be measured for the primary outcome.
Time frame: After 4 weeks of treatment time
Number of patients reaching serum phosphate levels < 1.76 mmol/L. this study to evaluate the safety profile of OsvaRen® granules. in comparison to OsvaRen® tablets. Especially serum calcium, magnesium, and PTH are of interest.
Time frame: Between the first and last visit under each treatment i.e. 4 weeks
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Flensburg, Germany
Nephrocare Hamburg-Barmbek GmbH
Hamburg, Germany
Dialysezentrum
Hanover, Germany
Dialysezentrum
Kiel, Germany
Dialysezentrum
Magdeburg, Germany
Dialysezentrum
Minden, Germany
Dialysezentrum
Solingen, Germany
...and 1 more locations