At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 145 enrolled
Drug / intervention
Everolimus +3 moredrug
Likely dose
Everolimus 1.5 mgfrom 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.
A 6-month, Multicenter, Randomized, Open-label Study of Safety and Efficacy of Everolimus-based Regimen Versus Calcineurin Inhibitor (CNI)-Based Regimen in Maintenance Liver Transplant Recipients
In Brief
A Phase 3 clinical trial evaluating Everolimus, Calcineurin inhibitors (CNI), and 2 other interventions for Liver Transplantation. Completed, enrolled 145 participants across 2 sites in 2 countries.
Detailed Summary
The purpose of the study is to assess the effect of everolimus initiation together with reduction or discontinuation of calcineurin inhibitor (CNI) on renal function in maintenance liver transplant recipients with CNI-related renal impairment, while maintaining efficacy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Transplantation
CountriesGermany, Switzerland
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2005
First PostedDec 2005
Primary CompletionNov 2007
TodayJul 2026
First PostedDec 20, 2005
Enrollment StartNov 1, 2005
Primary CompletionNov 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 20.5 years ago
Interventions
Everolimusdrug
1.5 mg bid adjusted in order to achieve a trough level between 3 and 8 ng/mL while in combination with CNI and between 6 and 12 ng/mL after CNI discontinuation
Calcineurin inhibitors (CNI)drug
Mycophenolate acid (MPA)/ Azathioprine (AZA)drug
Steroidsdrug