CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 285 enrolled
Drug / intervention
Everolimus + reduced tacrolimus +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01888432
NCT01888432Phase 3Completed
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A 24 Month, Randomized, Controlled, Study to Evaluate the Efficacy and Safety of Concentration-controlled Everolimus Plus Reduced Tacrolimus Compared to Standard Tacrolimus in Recipients of Living Donor Liver Transplants and Long Term Extension to Evaluate the Efficacy and Safety of Concentration-controlled Everolimus Plus Reduced Tacrolimus Compared to Standard Tacrolimus in Recipients of Living Donor Liver Transplants in Japan

Novartis Pharmaceuticals·interventional·Posted Jun 27, 2013·Updated Mar 18, 2019

In Brief

A Phase 3 clinical trial evaluating Everolimus + reduced tacrolimus and Standard tacrolimus for Liver Transplantation. Completed, enrolled 285 participants across 42 sites in 13 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Transplantation
CountriesCanada, Egypt, Germany, India, Italy, Japan, Russia, Saudi Arabia, Singapore, South Korea, Taiwan, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 27, 2013
Enrollment StartSep 25, 2013
Primary CompletionOct 19, 2016
Study CompletionApr 21, 2018
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 13.0 years ago

Interventions

Everolimus + reduced tacrolimusdrug

Everolimus was initiated at Week 4 post transplantation. The dose was adjusted to maintain the everolimus trough blood levels between 3-8 ng/mL for the duration of the study. Tacrolimus was reduced to 3-5 ng/mL.

Standard tacrolimusdrug

Tacrolimus was initiated as soon as possible after transplantation according to approved labeling recommendations. The trough level should've been 5-15 ng/mL until randomization, 8-12 ng/mL from randomization until month 4 and after month 4 until end of study reduced to 6 -10 ng/mL.