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

Phase 4

• Conditions: Kidney Transplantation

• Registration Number: NCT00204191
• Lead Sponsor: Uniwersytet Mikolaja Kopernika w Toruniu

Brief 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.

Detailed 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 Timeline

• Study Start: 2003-05
• Status Verified: 2005-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Last Update Submitted: 2007-10-18
• Last Update Posted: 2007-10-19
• Study Completion: 2007-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
patient survival	at one year
graft survival	at one year

Secondary Outcome Measures

Name	Time	Method
renal function measured by serum creatinine (SCr)	at one year
lipid profile	throughout the study
total cost of the treatment

Trial Locations

Locations (1)

Klinika Transplantologii, Szpital Uniwersytecki, ul. M. Sklodowskiej-Curie 9; 🇵🇱 Bydgoszcz, Poland