Comparison of the Two Immunosuppressive Regimens Based on Tacrolimus and Cyclosporine Following Kidney Transplantation
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|ClinicalTrials.gov Identifier: NCT00204191|
Recruitment Status : Unknown
Verified September 2005 by Uniwersytet Mikolaja Kopernika w Toruniu.
Recruitment status was: Recruiting
First Posted : September 20, 2005
Last Update Posted : October 19, 2007
|Condition or disease||Intervention/treatment||Phase|
|Kidney Transplantation||Drug: tacrolimus||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2003|
|Estimated Study Completion Date :||December 2007|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00204191
|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|