Conversion From Tacrolimus to Cyclosporine Microemulsion in Liver Transplant Patients With New Onset Diabetes After the 3rd Month Post-transplant

Study Overview
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Brief Summary
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The trial is conducted in patients who have received a liver transplant, were prescribed tacrolimus to prevent organ rejection and developed diabetes from 3 month post-transplantation onwards. The goal of the trial is to assess the percentage of patients in whom diabetes will resolve 6 month after conversion from tacrolimus to cyclosporine micro-emulsion as measured by a fasting blood glucose < 1,26 g/l without the need of hypoglycemic treatment.

Official Title
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Pilot Study of the Conversion From Tacrolimus to Cyclosporine Microemulsion in Liver Transplant Patients Presenting With New Onset Diabetes After the 3rd Month Post-transplant.

Conditions
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Maintenance Liver Transplant Patients With New Onset Diabetes

Intervention / Treatment
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* Drug: Cyclosporine - cyclosporine microemulsion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Patients who have received a first liver transplantation and who are 18 to 70 year old Patients who are treated with tacrolimus post-transplant for at least 3 months and for a maximum of 36 months Patients without any known diabetes before transplantation and in whom diabetes mellitus was diagnosed for the first time at least 3 months post-transplantation Exclusion Criteria Re-transplantation or multi-organ transplantation, Diabetes before the transplantation, Type I diabetes mellitus. Other protocol-defined inclusion / exclusion criteria may apply

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: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cyclosporine - cyclosporine microemulsion|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of patients whose diabetes resolves 6 months after the conversion (fasting glucose < 1.26 g/L without hypoglycemic treatment). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of patients whose diabetes has resolved 1 year after the conversion (fasting glucose < 1.26 g/L without hypoglycemic treatment). |  |  | 
| % of patients treated with insulin and oral ant diabetics and status of the drug doses 6 months and 1 year after the conversion. |  |  | 
| % of patients with HbA1c ≤ 7% 6 months and 1 year after the conversion. |  |  | 
| Blood pressure % of patients with a diastolic value ≥ 90 mmHg, mean systolic and diastolic values, |  |  | 
| % of patients receiving antihypertensive treatment), |  |  | 
| BMI, kidney function (creatinine and creatinine clearance), microalbuminuria, hyperlipidemia, adverse events, serious adverse events, dropouts, at 6 months and at 1 year. |  |  | 
| Incidence of acute and chronic rejection treated at 6 months and at 1 year. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cyclosporine, liver transplantation, maintenance, diabetes