drugset / Trial / NCT01625377
A National Multi-center Randomized, Open Label Study to Evaluate Efficacy and Safety of Everolimus With EC-MPS Compared to Standard Treatment Combination Tacrolimus and EC-MPS in de Novo Liver Transplant Recipients
RandomizedParallel-groupOpen-labelTreatment
Summary
The aims of the study was to evaluate the safety and efficacy of early introduction one month post-transplantation of everolimus associated to EC-MPS with tacrolimus discontinuation in de novo liver transplant recipients and to evaluate if it leads to a better renal function 6 month post-transplantation compared to standard treatment associating tacrolimus and EC-MPS. The renal function was estimated by glomerular filtration rate.
Timeline
- Start
- 2012-12
- Primary completion
- 2015-03
- Completion
- 2015-03
Outcome
Met primary endpoint
registry analysis (superiority or other test); Tacrolimus vs Everolimus (RAD001); p <0.0001; Mean Difference (Net) -14.34 (95% CI -21.34 to -7.34); ANCOVA NCT01625377 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Everolimus | Small molecule | 2 mg | — |
| Subject | Tacrolimus | Small molecule | — | — |
| Background | Basiliximab | Monoclonal antibody | 20 mg | — |
| Background | Corticosteroids | Unknown | — | Oral |
| Background | mycophenolic acid | Small molecule | 1440 mg | — |
Indications
No indication recorded.