Efficacy and Safety of Cyclosporine Microemulsion Given Once a Day in Adult Stable Liver Transplant Recipients

A Multicenter, Randomized Open-label Pilot Study to Explore the Benefit of a Conversion From a Twice a Day Administration of Cyclosporine Microemulsion to a Once a Day Administration and to Identify the C2 Ranges to Target After Conversion in Stable Liver Transplant Recipients

The purpose of this study is to determine whether cyclosporine microemulsion given once a day instead of twice a day benefits kidney function, blood pressure, lipid profile and glucose control in stable liver transplant recipients. The study also aims to identify the target ranges of levels of cyclosporine microemulsion in the blood.

Inclusion Criteria:

• At least 6 months post-transplant
• At least one of the following: stable or deteriorating kidney function, high blood pressure, high lipids, high glucose
• Receiving stable doses of cyclosporine microemulsion for the past 3 months

Exclusion Criteria:

• - Severe rejection within the past 3 months
• Severe kidney dysfunction
• Transplanted for hepatitis C or autoimmune hepatitis

Other protocol-defined exclusion criteria applied