PREventing Delayed Graft Function by Driving Immunosuppressive InduCtion Treatment (PREDICT-DGF): study protocol for a randomized controlled trial
BACKGROUND An evaluation of the long-term efficacy and incidence of adverse events after induction therapy with antithymocyte globulin (ATG) vs. Basiliximab in renal transplant patients. METHODS Sixty recipients receiving ATG induction and a dual immunosuppression with Tacrolimus and steroids were compared retrospectively with 60 patients treated with Basiliximab. The following characteristics were evaluated: concomitant immunosuppression, recipient age, donor age, time on dialysis, cold ischemia time, year of transplantation and HLA mismatches. RESULTS The 6-year patient survival in the ATG group was 91·7% compared to 85% in the Basiliximab group (not significant, n.s.). Graft survival at 6 years was 89·7% and. 83·6% in the ATG and the Basiliximab group (n.s.), respectively. Incidence of biopsy proven acute rejection episodes (33·3% vs. 26·7%) and delayed graft function (30% vs. 33·3%) were similar in both groups. Kidney function was not significantly different at 1 and 6 years. CMV infections were more prevalent in the ATG arm (22% vs. 5%; P = 0·05), and a significantly higher rate of haematological complications was observed following ATG induction. CONCLUSIONS ATG induction was associated with an improved (but n.s.) trend in patient and graft survival. Patients induced with ATG had a higher rate of CMV infections and haematological complications.