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

Kidney Transplantation Clinical Trial

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

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Transplantation

• NCT number: NCT00204191
• Study type: Interventional
• Source: Uniwersytet Mikolaja Kopernika w Toruniu
• Contact: Zbigniew Wlodarczyk, MD, PhD
• Phone: +48 52 585 4044
• Email: kiktranspl@cm.umk.pl
• Status: Recruiting
• Phase: Phase 4
• Start date: May 2003
• Completion date: December 2007