Modified Release Tacrolimus in De Novo Immunosuppression After Simultaneous Pancreas-Kidney Transplantation-A First Single-Center Experience

Background. Modified release tacrolimus is a new, once-daily oral formulation of the established immunosuppressive agent tacrolimus. Little is known about de novo, immunosuppression after simultaneous pancreas-kidney transplantation using modified release tacrolimus. Methods. To test the feasibility of modified release tacrolimus in simultaneous pancreas-kidney transplantation (SPK), we conducted a prospective study of 14 consecutive transplants using modified release tacrolimus (Advagraf, ADV), mycophenolate mofetil, and low-dose corticosteroids as the initial immunosuppressive regimen. Patient and graft survival, the rates of acute rejection, graft function as well as ADV dosages, and trough levels (C(min)) were investigated after a mean follow-up time of 11.0 +/- 3.1 months. Results. Overall patient, kidney, and pancreas graft survival were 100%, 100%, and 93%, respectively. One pancreas graft was lost owing to vascular graft thrombosis 2 days after transplantation. The incidence of rejection episodes at 11 months was 38%. ADV was well tolerated in the majority of patients. Only in I case tacrolimus (ADV) was stopped because of psychotic symptoms. In week 2 and 3 posttransplant, a significant adjustment in the ADV dosage was necessary to achieve sufficient tacrolimus trough levels. Conclusions. The results of this case series report demonstrate that patients after SPK can be safely treated with modified release tacrolimus. Further studies are needed to investigate pharmacokinetic profiles of modified release tacrolimus after SPK.