CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 56 enrolled
Drug / intervention
Introduction of everolimus with reduced cyclosporine or tacrolimus dose, the earliest 1 month and the latest 6 months after liver transplantation.drug
Likely dose
Introduction of everolimus with reduced cyclosporine or tacrolimus dose, the earliest 1 month and the latest 6 months after liver transplantation. 0.8 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.

Search/NCT01598987
NCT01598987Phase 3Completed
CompareCT.gov

A 24-month, Multi-center, Single Arm, Prospective Study to Evaluate Renal Function, Efficacy, Safety and Tolerability of Everolimus in Combination With Reduced Exposure Cyclosporine or Tacrolimus in Paediatric Liver Transplant Recipients.

Novartis Pharmaceuticals·interventional·Posted May 15, 2012·Updated May 16, 2017

In Brief

A Phase 3 clinical trial evaluating Introduction of everolimus with reduced cyclosporine or tacrolimus dose, the earliest 1 month and the latest 6 months after liver transplantation. for Renal Function and Liver Transplant. Completed, enrolled 56 participants across 32 sites in 12 countries.

Detailed Summary

This study was designed to assess the evolution of renal function and to collect efficacy, safety, and tolerability data of everolimus in co-exposure with reduced CNI in paediatric liver transplant recipients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Function, Liver Transplant
CountriesAustralia, Belgium, Canada, Denmark, France, Germany, Hungary, Italy, Spain, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 15, 2012
Enrollment StartOct 1, 2012
Primary CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 14.1 years ago

Interventions

Introduction of everolimus with reduced cyclosporine or tacrolimus dose, the earliest 1 month and the latest 6 months after liver transplantation.drug

Immunosuppression after liver transplantation. Pediatric transplant recipients received a starting dose of 0.8 mg/m\^2/dose in combination wit Cyclosporine A or 2.0 mg/m\^2/dose in combination with tacrolimus, twice-daily. Thereafter, doses were adjusted to achieve everolimus C-0h blood trough level between 3 to 8 ng/ml.