drugset / Trial / NCT00149994
Cyclosporine A C-2h Monitoring Versus Tacrolimus C-0h Monitoring in de Novo Liver Transplant Recipients
RandomizedFactorialOpen-labelPrevention
Summary
The purpose of this study is to determine whether cyclosporine A (in a micro emulsion formulation) monitored by sample taken 2 hour after oral dose (C-2h) will show equivalent or superior efficacy compared to tacrolimus monitored by pre-dose blood concentration (C-0h). In addition this study will assess the safety and tolerability of a cyclosporine A regimen based on C-2h monitoring in comparison to the standard tacrolimus regimen.
Timeline
- Start
- 2002-12
- Primary completion
- 2007-12
- Completion
- 2007-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclosporine | Peptide | 10 mg/kg | Oral |
| Subject | Cyclosporine | Peptide | 15 mg/kg | Oral |
| Comparator | Tacrolimus | Small molecule | 0.1 mg/kg | Oral |
| Comparator | Tacrolimus | Small molecule | 0.15 mg/kg | Oral |
| Background | Basiliximab | Monoclonal antibody | 20 mg | Intravenous |
| Background | Methylprednisolone | Other / unclassified | 500 mg | Intravenous |
| Background | Prednisone | Other / unclassified | 5 mg | — |
| Background | Prednisone | Other / unclassified | 10 mg | — |
Indications
No indication recorded.