drugset / Trial / NCT01551212
Efficacy of Everolimus in Combination With Tacrolimus in Liver Transplant Recipients
RandomizedParallel-groupOpen-labelTreatment
Summary
This trial evaluated the efficacy and safety of Everolimus in combination with tacrolimus versus a standard immunosuppressive regimen concerning kidney function in liver transplant recipients.
Timeline
- Start
- 2012-05-24
- Primary completion
- 2017-08-08
- Completion
- 2017-08-08
Outcome
Missed primary endpoint
registry analysis (superiority test); Everolimus/Tacrolimus vs Tacrolimus; p = 0.097; Mean Difference (Final Values) 4.09 (95% CI -0.74 to 8.91); ANCOVA NCT01551212 ↗
Publications
- Nashan B, Schemmer P, Braun F, Schlitt HJ, Pascher A, Klein CG, Neumann UP, Kroeger I, Wimmer P; Hephaistos Study Group. Early Everolimus-Facilitated Reduced Tacrolimus in Liver Transplantation: Results From the Randomized HEPHAISTOS Trial. Liver Transpl. 2022 Jun;28(6):998-1010. doi: 10.1002/lt.26298. Epub 2021 Oct 12.
- Nashan B, Schemmer P, Braun F, Dworak M, Wimmer P, Schlitt H. Evaluating the efficacy, safety and evolution of renal function with early initiation of everolimus-facilitated tacrolimus reduction in de novo liver transplant recipients: Study protocol for a randomized controlled trial. Trials. 2015 Mar 26;16:118. doi: 10.1186/s13063-015-0626-0.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Everolimus | Small molecule | 0.25 mg | — |
| Subject | Everolimus | Small molecule | 0.5 mg | — |
| Subject | Everolimus | Small molecule | 0.75 mg | — |
| Subject | Everolimus | Small molecule | 1 mg | — |
| Subject | Tacrolimus | Small molecule | 0.5 mg | — |
| Subject | Tacrolimus | Small molecule | 1 mg | — |
| Subject | Tacrolimus | Small molecule | 5 mg | — |
Indications
No indication recorded.