Evaluation of Cyclosporine Microemulsion and Tacrolimus on the Rate of New Onset Diabetes Mellitus in Kidney Transplantation Recipients

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the impact of tacrolimus and cyclosporine microemulsion on glucose metabolism in kidney transplant recipients and the efficacy and safety in preventing organ rejection

Official Title
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A Six-month Open Label, Multicenter, Randomized Study to Evaluate the Incidence of New Onset Diabetes Mellitus and Glucose Metabolism in Patients Receiving Cyclosporine Microemulsion With C-2 Monitoring Versus Tacrolimus After de Novo Kidney Transplantation

Conditions
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Kidney Transplant

Intervention / Treatment
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* Drug: Cyclosporine microemulsion
* Drug: Tacrolimus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - First or second transplant, cadaveric or living donor Exclusion Criteria: Multi-organ or dual kidney transplants Panel reactive antibodies >50% Other protocol-defined inclusion/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

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cyclosporine microemulsion<br> | Drug: Cyclosporine microemulsion<br> <br> |
| Active Comparator: Tacrolimus<br> | Drug: Tacrolimus<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of NODM or impaired fasting glucose (IFG) in de novo kidney transplant patients receiving cyclosporine microemulsion versus in patients receiving tacrolimus within the first 6 months post-transplantation. |  |  | 
| Incidence of biopsy-proven acute rejection (BPAR) or graft loss or death within the first 6 months post-transplantation. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of NODM or IFG within the first 3 mths post-transplantation in pts treated with cyclosporine microemulsion or tacrolimus |  |  | 
| percentage of pts with preexisting diabetes at transplantation who have a glycosylated hemoglobin level >7% at Mths 3 &6 post-transplantation |  |  | 
| Change over time of mean HbA1c at mths 3 &6 post-transplantation in pts w/ preexisting diabetes at transplantation |  |  | 
| percentage of pts who switched from oral hypoglycemic agents to insulin within 3 &6 mths post-transplantation |  |  | 
| incidence of impaired glucose tolerance (IGT) as assessed by an oral glucose tolerance test (OGTT) |  | 6 months | 
| Blood pressure at Months 3& 6 post-transplantation |  |  | 
| incidence of BPAR or graft loss or death within the first 3 months post-transplantation, as well as the incidence of each individual event within 3 and 6 months post-transplantation. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney transplant, adults, NODM, immunosuppressants