%0 Journal Article
%T Clinical Trial for the Evaluation of Efficacy and Safety of Tacrolimus in Combination with 1g MMF after Renal Transplantation
%A M. Maruschke
%A G. Kramer
%A H. Seiter
%J Transplantationsmedizin
%D 2004
%I Pabst Science Publishers
%X Aims of the Study: The objective of this investigation was to extend the experience in the use of tacrolimus as primary immunosuppressant after kidney transplantation. Furthermore the safety profile and the immunosuppressive efficacy of tacrolimus in combination with dose-reduced MMF was to be evaluated. Methods: After cadaveric renal transplantation 13 patients (9 male and 4 female) with a mean age of 42 years (range 21-66 years) were included into this study. They received an immunosupressive regimen of tacrolimus, dose-reduced MMF (1g / day) and steroids. The patients were followed up for 6 months. Endpoints were time to first acute or steroid resistant rejection and incidence and grade of rejections. Secondary endpoints were laboratory parameters as serum creatinine, glucose levels, lipids, other side effects and patient and graft survival. Results: A primary graft function was obtained in 8 patients (61,5 %), a delayed graft function (DGF) in 5 patients (38,5 %). One patient (ca. 8%) had a biopsy-confirmed acute rejection. In 2 patients (15,4 %) tacrolimus had to be discontinued due to prolonged DGF and concommittant high tacrolimus trough levels. The functional impairments were partly reversible. After changing the immunosuppressive therapy the patients showed a normal graft function. The courses of serum creatinine levels showed a decreasing tendency. Glucose levels were stable in the normal range throughout the study. No hyperglycemia and no case of post transplant diabetes mellitus was observed. Conclusion: In this study we could confirm that tacrolimus is an effective and safe immunosuppressive drug offering good handling and a balanced side effect profile. It may be optimally used as primary immunosuppressant after kidney transplantation in combination with dose reduced MMF (1g/day) providing an adequate immunosuppression.
%K renal transplantation
%K primary immunosuppression
%K tacrolimus
%K graft function
%K acute rejection
%U http://www.transplantation.de/fileadmin/transplantation/txmedizin/txmedizin_2004_2/Maruschke.pdf