122
Participants
Start Date
February 29, 2008
Primary Completion Date
August 31, 2010
Study Completion Date
May 31, 2012
Everolimus
0.75 mg twice daily, trough level adjusting between 3 and 8 ng/ml.
Mycophenolate mofetil (MMF)
The initial dose of 2 gm/day Mycophenolate mofetil was started within 24-36 hours from reperfusion after transplantation. MMF was administered daily for 12 months in the core study and 12 months in the extension study.
Basiliximab
Patients received first dose of basiliximab (20 mg) 2 hours prior to transplantation and 20 mg at Day 4 or according to local practice
Cyclosporine A
The cyclosporine was initiated either pre-transplant or within 24 hours after transplantation following local regime. Standard dose of cyclosporine was administered with MMF. The Reduced dose of cyclosporine was administered with everolimus.
Corticosteroid
Corticosteroid was administered according to local practice during the trial but at a dose not less than 5mg per day for 12 months of the study
Novartis Pharma K.K., Japan, Tokyo
Lead Sponsor
Novartis
INDUSTRY