drugset / Trial / NCT02909335
De Novo Everolimus Versus Tacrolimus in Combination With Mofetil Mycophenolate and Low Dose Corticosteroids to Reduce Tacrolimus Induced Nephrotoxicity in Liver Transplantation: a Prospective, Multicentric, Randomised Study
RandomizedParallel-groupOpen-labelPrevention
Summary
Tacrolimus is a calcineurin inhibitor. This is the immunosuppression of reference for patients undergoing a first liver transplant. This treatment can prevent graft rejection, but can cause side effects including kidney failure (in 25% after the first year). Everolimus is an immunosuppressive that effectively prevents acute rejection in heart and kidney transplant recipients. It preserves renal function when it is started soon after the transplant, i.e. before a severe dysfunction is installed.
Timeline
- Start
- 2016-11
- Primary completion
- 2021-11
- Completion
- 2021-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Everolimus | Small molecule | 1.5 mg | — |
| Subject | Tacrolimus | Small molecule | 0.04 mg/kg | — |
| Background | Methylprednisolone | Other / unclassified | — | — |
| Background | Mycophenolate Mofetil | Small molecule | 1 g | — |
| Background | Prednisolone | Other / unclassified | — | — |
| Background | Prednisone | Other / unclassified | — | — |
Indications
No indication recorded.