NCT01423708

Everolimus in de Novo Liver Transplantation: a Multicentre Randomized Study

Terapia Con Everolimus Nel Trapianto de Novo di Fegato: Uno Studio Multicentrico Randomizzato

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 117 (estimated)
• Sponsor: Azienda Ospedaliera di Padova · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Safety and Efficacy of Everolimus in adult de novo liver transplant recipients.

Detailed description

This prospective study was designed to evaluate the feasibility and effectiveness of the use of Everolimus in the minimization and possible suspension of calcineurin inhibitors in adult liver transplant patients. The study will take into account a control group (standard immunosuppression with tacrolimus and steroids) after induction with anti-IL2 Antibodies.

Conditions

• Liver Failure
• Liver Diseases
• Liver Cirrhosis
• Liver Neoplasms

Interventions

Type	Name	Description
DRUG	Everolimus	Administration of Everolimus within 24 hours from the time of randomization (7 days from the time of transplantation) in association with Tacrolimus and steroids. The first dose level of the trough will be performed at day 7 after initiation of therapy. After the reaching an Everolimus trough level of \>5ng/ml (final target 6-12 ng/ml), there will be a gradual weaning of tacrolimus (bringing Tacrolimus blood levels \<5 ng/ml) with discontinuation of Tacrolimus within 30 days after transplantation when possible.

Timeline

• Start date: 2010-02-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2011-08-26
• Last updated: 2012-07-18

Locations

7 sites across 1 country: Italy