NCT01551212

Efficacy of Everolimus in Combination With Tacrolimus in Liver Transplant Recipients

A 12-month, Multi-center, Open-label, Randomized, Controlled Study to Evaluate Efficacy/Safety and Evolution of Renal Function of Everolimus in Co-exposure With Tacrolimus in de Novo Liver Transplant Recipients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 339 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This trial evaluated the efficacy and safety of Everolimus in combination with tacrolimus versus a standard immunosuppressive regimen concerning kidney function in liver transplant recipients.

Conditions

• Liver Transplantation

Interventions

Type	Name	Description
DRUG	Everolimus	tablet containing 0.25mg, 0.5mg, 0.75mg or 1.0mg
DRUG	Tacrolimus	capsule containing 0.5, 1.0, or 5.0mg
DRUG	Corticosteroids	For patients in all groups, corticosteroids were initiated at or prior to the time of transplantation according to local practice. Corticosteroids may have been used for the duration of the study according to the investigator's discretion, but may not have been eliminated sooner than 6 months post-transplantation.

Timeline

• Start date: 2012-05-24
• Primary completion: 2017-08-08
• Completion: 2017-08-08
• First posted: 2012-03-12
• Last updated: 2019-05-10
• Results posted: 2019-05-10

Locations

15 sites across 1 country: Germany