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
Overview
- Phase
- Phase 4
- Intervention
- Cyclosporine microemulsion
- Conditions
- Liver Transplant
- Sponsor
- Novartis
- Enrollment
- 61
- Primary Endpoint
- Investigation of the proportion of patients with an improving GFR in the groups converted to OAD in comparison with the BID group 15 weeks after conversion.
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
BID cyclosporine
control group continuing with a BID administration of cyclosporine and C2 monitoring.
Intervention: Cyclosporine microemulsion
OAD cyclosporine
conversion to OAD administration of cyclosporine with the same daily dose as received prior to conversion
Intervention: Cyclosporine microemulsion
OAD cyclosporine reduced
OAD administration of cyclosporine with a daily dose adjusted to a reduced C2
Intervention: Cyclosporine microemulsion
Outcomes
Primary Outcomes
Investigation of the proportion of patients with an improving GFR in the groups converted to OAD in comparison with the BID group 15 weeks after conversion.
Secondary Outcomes
- assess the safety of a once a day administration of cyclosporine microemulsion.
- compare for each patient the C2 levels pre- and post-conversion.
- characterize the steady state pharmacokinetics of cyclosporine after conversion to once a day administration.
- the proportion of patients with improving renal function or blood pressure or lipid levels or glucose control (as a composite end point as well as each parameter assessed individually)(4 months)