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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BID cyclosporine | Active Comparator | control group continuing with a BID administration of cyclosporine and C2 monitoring. |
|
| OAD cyclosporine | Experimental | conversion to OAD administration of cyclosporine with the same daily dose as received prior to conversion |
|
| OAD cyclosporine reduced | Experimental | OAD administration of cyclosporine with a daily dose adjusted to a reduced C2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclosporine microemulsion | Drug |
|
| Measure | Description | 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. |
| Measure | Description | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined exclusion criteria applied
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis | Study Director |
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| 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 |