Trial | NCT00204191  Report issue

Title

Comparison of the Two Immunosuppressive Regimens Based on Tacrolimus and Cyclosporine Following Kidney Transplantation
Open, Prospective, Randomized Study to Compare the Efficacy and Safety of Immunosuppression Regimens Based on Cyclosporine (Neoral®) and Tacrolimus (Prograf®) in Renal Transplant Patients

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    tacrolimus ...

  • Study Participants

    300
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.
Study Started
May 31
2003
Study Completion
Dec 31
2007
Last Update
Oct 19
2007
Estimate

Drug tacrolimus

Criteria 

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
No Results Posted