Comparison of the Two Immunosuppressive Regimens Based on Tacrolimus and Cyclosporine Following Kidney Transplantation
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- graft survival [ Time Frame: at one year ]
- patient survival [ Time Frame: at one year ]
- renal function measured by serum creatinine (SCr) [ Time Frame: at one year ]
- lipid profile [ Time Frame: throughout the study ]
- total cost of the treatment
|Study Start Date:||May 2003|
|Estimated Study Completion Date:||December 2007|
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.
|Contact: Zbigniew Wlodarczyk, MD, PhD||+48 52 585 firstname.lastname@example.org|
|Klinika Transplantologii, Szpital Uniwersytecki, ul. M. Sklodowskiej-Curie 9||Recruiting|
|Bydgoszcz, Poland, 85-084|
|Principal Investigator: Zbigniew Wlodarczyk, MD|
|Sub-Investigator: Andrzej Adamowicz, MD|
|Principal Investigator:||Zbigniew Wlodarczyk, MD, PhD||Klinika Transplantologii, Collegium Medicum UMK Torun|