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.

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.

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