Efficacy and Safety of Everolimus in Liver Transplant Recipients of Living Donor Liver Transplants

Phase 3 Completed 285 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupSingle-blindTreatment

Summary

The purpose of this trial was to demonstrate the efficacy and safety of everolimus in combination with reduced tacrolimus, compared to tacrolimus control, in living donor liver transplant recipients.

Timeline

Start: 2013-09-25
Primary completion: 2016-10-19
Completion: 2018-04-21

Outcome

Met primary endpoint

paper EVR+rTAC was non-inferior to TAC Control for the primary efficacy endpoint of treated BPAR, graft loss or death at 12 months posttransplant PMID 29237235 ↗

Publications

Jeng LB, Lee SG, Soin AS, Lee WC, Suh KS, Joo DJ, Uemoto S, Joh J, Yoshizumi T, Yang HR, Song GW, Lopez P, Kochuparampil J, Sips C, Kaneko S, Levy G. Efficacy and safety of everolimus with reduced tacrolimus in living-donor liver transplant recipients: 12-month results of a randomized multicenter study. Am J Transplant. 2018 Jun;18(6):1435-1446. doi: 10.1111/ajt.14623. Epub 2018 Jan 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Everolimus	Small molecule	—	—
Comparator	Tacrolimus	Small molecule	—	—

Indications

No indication recorded.