Safety and Efficacy of Converting Maintenance Kidney and Liver Transplant Recipients With Abnormal Glucose Metabolism From Tacrolimus to Cyclosporine Micro-emulsion

Study Overview
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Brief Summary
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New onset diabetes mellitus (NODM) post- transplantation decreases patient and graft survival. Some immunosuppressive agents are associated with a higher incidence of NODM. This study evaluates the safety and efficacy of converting patients with NODM from tacrolimus to cyclosporine micro-emulsion as a primary immunosuppressant for kidney and liver recipients.

Official Title
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A Prospective, Randomized, Open-label, Twenty-six Week Study of the Efficacy and Safety of Converting Kidney and Liver Transplant Recipients With Tacrolimus-associated Abnormal Glucose Metabolism to Cyclosporine Micro-emulsion With C2 Monitoring

Conditions
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Tacrolimus-associated Abnormal Glucose Metabolism in Kidney and Liver Transplant Recipients

Intervention / Treatment
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* Drug: cyclosporine micro-emulsion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Recipients of first or second cadaveric or living donor kidney transplantation or first cadaveric or living donor liver transplantation Receiving tacrolimus as a primary immunosuppressant Currently on any diabetic agent or meets the American Diabetes Association definition of diabetes mellitus Exclusion Criteria: History of treated diabetes mellitus prior to transplantation Less than 2 weeks post-transplantation for kidney and less than 8 weeks for liver Greater than 36 months post-transplantation Onset of diabetes is greater than 12 months prior to time of study entry Has unacceptable or unstable graft function Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cyclosporine micro-emulsion|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who no longer require a hypoglycemic agent, or who move from insulin to an oral agent, or who no longer meet the American Diabetes Association criteria, or a relative improvement in mean glycosylated hemoglobin at 12 and 26 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed by death, graft loss, biopsy supported clinically manifested acute rejection, change in kidney function, change in liver function, serious adverse events and adverse events at 12 and 26 weeks |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, glucose, tacrolimus, cyclosporine micro-emulsion, liver, kidney, renal