NCT01625377

A National Multi-center Randomized, Open Label Study to Evaluate Efficacy and Safety of Everolimus With EC-MPS Compared to Standard Treatment Combination Tacrolimus and EC-MPS in de Novo Liver Transplant Recipients

A National, Multi-center, Randomized, Open Label Study to Evaluate the Efficacy and Safety of Everolimus Combined With Enteric-coated Mycophenolate Sodium Compared to the Standard Treatment Combining Tacrolimus and Enteric-coated Mycophenolate Sodium in de Novo Liver Transplant Recipients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 188 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aims of the study was to evaluate the safety and efficacy of early introduction one month post-transplantation of everolimus associated to EC-MPS with tacrolimus discontinuation in de novo liver transplant recipients and to evaluate if it leads to a better renal function 6 month post-transplantation compared to standard treatment associating tacrolimus and EC-MPS. The renal function was estimated by glomerular filtration rate.

Conditions

• Liver Transplantation

Interventions

Type	Name	Description
DRUG	tacrolimus	Arm 1 : tacrolimus (C0 6-10 ng/ml) from D3-D5 post-transplantation to month 6 post-transplantation. Arm 2 : tacolimus (C0 6-10 ng/ml) from D3-D5 post-transplantation to 16 weeks post-transplantation at the latest.
DRUG	everolimus	Arm 1: no everolimus Arm 2: everolimus (C0 6-10 ng/ml) from randomization to month 6 post-transplantation
DRUG	Basiliximab	Basiliximab was supplied to the participating centers as marketed, i.e. in packs containing one vial of 20-mg powder, and water for injection (WFI). 20 mg at D0 and D4
DRUG	Mycophenolic Acid	Dose of 1440 mg/day from transplantation to month 6 post- transplantation
DRUG	Corticosteroids	Administration of oral corticosteroid therapy was at the discretion of the centers according to their usual practice

Timeline

• Start date: 2012-12-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2012-06-21
• Last updated: 2016-04-27
• Results posted: 2016-04-27

Locations

14 sites across 1 country: France