A 39-Month Follow-up Study to Evaluate the Safety and Efficacy in Kidney Transplant Recipients Treated With Modified-Release Tacrolimus (FK506E)-Based Immunosuppression Regimen.
Han DJ, Park JB, et al.Transplantation Proceedings, 44(1): 115-117, 2012.
Aims
1) To evaluate the safety and efficacy of modified release tacrolimus (FK506E) in living donor de novo kidney transplant recipients in the initial 6-month phase 3 study. 2) To evaluate the long-term safety and efficacy of a FK506E-based regimen in recipients treated with FK506E in the extension study.
Interventions
Modified release tacrolimus (Advagraf ) versus tacrolimus (Prograf). All patients received mycophenolate mofetil and steroids.
Participants
124 de novo living donor kidney transplant recipients who participated in the initial 6-month study, 44 out of 124 patients were followed up for 39-month extension study.
Outcomes
The primary endpoint of the initial 6-month study was the incidence of an acute allograft rejection episode within 6 months post-transplantation. The secondary endpoints of the initial study were requirement for anti-lymphocyte antibody therapy for rejection, renal function measured as serum creatinine, and patient and graft survivals at 6 months post-transplantation. The primary endpoint of the extension study was patient and graft survivals at 45 months post-transplantation. The secondary endpoint of the extension study was the incidence of a clinical or biopsy proven acute rejection episode
Follow-up
45 months post-transplantation
CET Conclusions
This trial is really a non-inferiority study and although the authors claim that this shows that the use of Advagraf daily is both effective and safe in comparison with Prograf, the study is not adequately powered to draw this conclusion.
Data analysis
Per protocol analysis
Trial registration
Not reported