Therapeutic Equivalence of OsvaRen® Tablets and OsvaRen® Granules (OsvaRenNEW)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02027662|
Recruitment Status : Completed
First Posted : January 6, 2014
Last Update Posted : June 10, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Hyperphosphatemia Chronic Kidney Disease||Drug: Osvaren Granules Drug: Osvaren film-coated tablets||Phase 2 Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study to Investigate Efficacy and Safety Equivalence of OsvaRen® Tablets and OsvaRen® Granules|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||June 2015|
Experimental: Osvaren Granules
Drug: Osvaren Granules
Active Comparator: Osvaren film-coated tablets
Osvaren film-coated tablets
Drug: Osvaren film-coated tablets
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02027662
|Georg-Haas-Dialysezentrum der PHV|
|Giessen, Hessen, Germany, 35392|
|RWTH University Hospital, Dpt for Nephrology|
|Aachen, NRW, Germany, 52074|
|Nephro-Studien GbR am Klinikum Erfurt|
|Flensburg, Germany, 24939|
|Nephrocare Hamburg-Barmbek GmbH|
|Hamburg, Germany, 22297|
|Kiel, Germany, 24106|
|Principal Investigator:||Jürgen Floege, MD||University Aachen|