drugset / Trial / NCT02115113

REnal Function in Liver Transplantation: Everolimus With Calcineurin Inhibitor (CNI)-Sparing sTrategy

NCT02115113

Phase 3 Completed 78 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study was, starting from the Italian clinical practice in liver transplantation, to optimize the immunosuppressive therapy, considering specific patient characteristics as alcoholic cirrhosis, hepatitis C virus (HCV), hepatocellular carcinoma (HCC), and short/long-term implications. Then efficacy and safety of a calcineurin inhibitor (CNI)-withdrawal regimen was evaluated in comparison with a CNI-minimization regimen.

Timeline

Start
2014-03-28
Primary completion
2016-09-30
Completion
2016-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Everolimus Small molecule 1 mg Oral
Subject Tacrolimus Small molecule Oral

Indications

No indication recorded.