Comparison of the Two Immunosuppressive Regimens Based on Tacrolimus and Cyclosporine Following Kidney Transplantation

Study Overview
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Brief Summary
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The purpose of this study is to evaluate and compare, in the single center setting, the safety, efficacy and cost-effectiveness of the two standard immunosuppressive regimens based on tacrolimus and cyclosporine.

Detailed Description
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Despite several multicenter studies, there is no hard evidence on the superiority of a cyclosporine or tacrolimus based immunosuppressive regimen following kidney transplantation, in a single-center setting. Existing studies concentrated on benefits in safety and efficacy, but seldomly evaluated the cost-effectiveness of one treatment. The study has been designed in a fashion as close to the daily clinical practice as possible. Patients are randomized in pairs, receiving kidneys from the same donor, thus avoiding donor-related bias. Those having specific indications or contraindications for one of the study medications were not entered into the study. All other study-related decisions are made only on a clinical basis and according to the standard practice of the center. Patients are followed on the intention-to-treat rule. Cost-effectiveness will be calculated on 12-month treatment for each patient entered into the study.

Official Title
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Open, Prospective, Randomized Study to Compare the Efficacy and Safety of Immunosuppression Regimens Based on Cyclosporine (Neoral®) and Tacrolimus (Prograf®) in Renal Transplant Patients

Conditions
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Kidney Transplantation

Intervention / Treatment
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* Drug: tacrolimus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First or second cadaveric kidney transplantation Age over 18 years old Specific indications or contraindications for cyclosporine or tacrolimus are absent Informed consent Exclusion Criteria: Specific indications for use of cyclosporine or tacrolimus Specific contraindications for use of cyclosporine or tacrolimus Participation in another interventional clinical trial Pregnancy or lactation

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: tacrolimus|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| graft survival |  | at one year | 
| patient survival |  | at one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| renal function measured by serum creatinine (SCr) |  | at one year | 
| lipid profile |  | throughout the study | 
| total cost of the treatment |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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kidney transplantation, Immunosuppression, Cyclosporine, Tacrolimus