CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 339 enrolled
Drug / intervention
Everolimus +2 moredrug
Likely dose
Everolimus 0.25mgfrom 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/NCT01551212
NCT01551212Phase 4Completed
CompareCT.gov

A 12-month, Multi-center, Open-label, Randomized, Controlled Study to Evaluate Efficacy/Safety and Evolution of Renal Function of Everolimus in Co-exposure With Tacrolimus in de Novo Liver Transplant Recipients

Novartis Pharmaceuticals·interventional·Posted Mar 12, 2012·Updated May 10, 2019

In Brief

A Phase 4 clinical trial evaluating Everolimus, Tacrolimus, and 1 other intervention for Liver Transplantation. Completed, enrolled 339 participants across 15 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Transplantation
CountriesGermany
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 12, 2012
Enrollment StartMay 24, 2012
Primary CompletionAug 8, 2017
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 14.3 years ago

Interventions

Everolimusdrug

tablet containing 0.25mg, 0.5mg, 0.75mg or 1.0mg

Tacrolimusdrug

capsule containing 0.5, 1.0, or 5.0mg

Corticosteroidsdrug

For patients in all groups, corticosteroids were initiated at or prior to the time of transplantation according to local practice. Corticosteroids may have been used for the duration of the study according to the investigator's discretion, but may not have been eliminated sooner than 6 months post-transplantation.