Clinical Trial Details
| Trial ID: | L0967 |
| Source ID: | NCT00182559 |
| Associated Drug: | Ciclosporin |
| Title: | The Vienna Prograf and Endothelial Progenitor Cell Study |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | End Stage Renal Disease |
| Interventions: | DRUG: Ciclosporin|DRUG: Tacrolimus |
| Outcome Measures: | Primary: Change in endothelial progenitor cells from baseline to month 24, The primary endpoint was the effect of conversion from ciclosporin to tacrolimus based immunosuppressive therapy on endothelial progenitor cell count at month 24., Baseline and 24 months | Secondary: Renal function at baseline and after 24 months, Changes in risk factors for cardiovascular outcomes like serum lipids, blood pressure, diabetes mellitus, serum C-reactive protein, body mass index. Safety was addressed according to the incidence of medical necessity to change immunosuppressive therapy, serious opportunistic infection, new-onset diabetes mellitus, cardiovascular events, malignancy, lymphoma and lymphoproliferative disease, gingival hyperplasia, hypertrichosis, alopecia, graft loss and death., Baseline, 24 months |
| Sponsor/Collaborators: | Sponsor: Medical University of Vienna |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 148 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE |
| Start Date: | 2004-04 |
| Completion Date: | 2009-05 |
| Results First Posted: | |
| Last Update Posted: | 2014-02-05 |
| Locations: | Medical University of Vienna, Vienna, 1090, Austria |
| URL: | https://clinicaltrials.gov/show/NCT00182559 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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