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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Liver Transplant

Intervention / Treatment
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* Drug: Cyclosporine microemulsion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BID cyclosporine<br>control group continuing with a BID administration of cyclosporine and C2 monitoring. | Drug: Cyclosporine microemulsion<br> <br> |
| Experimental: OAD cyclosporine<br>conversion to OAD administration of cyclosporine with the same daily dose as received prior to conversion | Drug: Cyclosporine microemulsion<br> <br> |
| Experimental: OAD cyclosporine reduced<br>OAD administration of cyclosporine with a daily dose adjusted to a reduced C2 | Drug: Cyclosporine microemulsion<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. |  |  | 

Secondary Outcome Measures

| Outcome Measure | 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. |  |  | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver transplant, adults, once a day administration, Immunosuppressants