Clinical Trial Details
| Trial ID: | L0566 |
| Source ID: | NCT02027662 |
| Associated Drug: | Osvaren Granules |
| Title: | Therapeutic Equivalence of OsvaRen® Tablets and OsvaRen® Granules |
| Acronym: | OsvaRenNEW |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Hyperphosphatemia|Chronic Kidney Disease |
| Interventions: | DRUG: Osvaren Granules|DRUG: Osvaren film-coated tablets |
| Outcome Measures: | Primary: Non-inferiority of phosphate control by granules versus tablets. Serum phosphate levels will be measured for the primary outcome., After 4 weeks of treatment time | Secondary: 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., Between the first and last visit under each treatment i.e. 4 weeks |
| Sponsor/Collaborators: | Sponsor: Fresenius Medical Care Deutschland GmbH |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2|PHASE3 |
| Enrollment: | 61 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2014-01 |
| Completion Date: | 2015-06 |
| Results First Posted: | |
| Last Update Posted: | 2015-06-10 |
| Locations: | Georg-Haas-Dialysezentrum der PHV, Giessen, Hessen, 35392, Germany|RWTH University Hospital, Dpt for Nephrology, Aachen, NRW, 52074, Germany|Nephro-Studien GbR am Klinikum Erfurt, Erfurt, Germany|Dialysezentrum, Flensburg, 24939, Germany|Nephrocare Hamburg-Barmbek GmbH, Hamburg, 22297, Germany|Dialysezentrum, Hannover, Germany|Dialysezentrum, Kiel, 24106, Germany|Dialysezentrum, Magdeburg, Germany|Dialysezentrum, Minden, Germany|Dialysezentrum, Solingen, Germany|Dialysezentrum, Velbert, Germany |
| URL: | https://clinicaltrials.gov/show/NCT02027662 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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