Clinical Trial Details
| Trial ID: | L0895 |
| Source ID: | NCT01200784 |
| Associated Drug: | Nicotinamide |
| Title: | Nicotinamide in Hemodialysis Patients With Hyperphosphatemia |
| Acronym: | DONATO |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Chronic Kidney Disease|Hemodialysis|Hyperphosphatemia |
| Interventions: | DRUG: Nicotinamide |
| Outcome Measures: | Primary: serum phosphate, 4 weeks of active treatment | Secondary: serum phosphate, 8 weeks of active treatment|serum calcium, 4 and 8 weeks of acitve treatment|serum PTH, 4 and 8 weeks of active treatment|adverse events, 12 weeks |
| Sponsor/Collaborators: | Sponsor: Medice Arzneimittel Pütter GmbH & Co KG |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2 |
| Enrollment: | 252 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2010-08 |
| Completion Date: | 2011-07 |
| Results First Posted: | |
| Last Update Posted: | 2012-01-18 |
| Locations: | Alsfeld, 36304, Germany|Arnstadt, 99310, Germany|Augsburg, 86157, Germany|Berlin Hellersdorf, 12627, Germany|Berlin Kreuzberg, 10245, Germany|Berlin, 12045, Germany|Berlin, 12203, Germany|Berlin, 12435, Germany|Berlin, 13051, Germany|Bielefeld, 33602, Germany|Coburg, 96450, Germany|Darmstadt, 64295, Germany|Dortmund, 44135, Germany|Dülmen, 48249, Germany|Düsseldorf, 40210, Germany|Elsenfeld, 63820, Germany|Erfurt, 99089, Germany|Essen, 45127, Germany|Friedrichsroda, 99894, Germany|Hamburg, 22297, Germany|Hameln, 31787, Germany|Herne, 44623, Germany|Herzberg, 04916, Germany|Iserlohn, 58638, Germany|Jena-Drakendorf, 07751, Germany|Kamen, 59174, Germany|Leverkusen, 51373, Germany|Mannheim, 68309, Germany|Minden, 32429, Germany|Nordhausen, 99734, Germany|Osnabrueck, 49074, Germany|Pfarrkirchen, 84347, Germany|Regensburg, 93053, Germany|Schwabach, 91126, Germany|Tangermünde, 39590, Germany|Wuppertal, 42283, Germany |
| URL: | https://clinicaltrials.gov/show/NCT01200784 |
