Liver Transplant
Conditions
Keywords
Liver transplant, adults, once a day administration, Immunosuppressants
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.
Interventions
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed