Prospective randomized trial of maintenance immunosuppression with rapid discontinuation of prednisone in adult kidney transplantation.
Suszynski TM, Gillingham KJ, et al.American Journal of Transplantation. 2013; 13(4):961-970.
Aims
To compare the long term outcomes of three maintenance immunosuppressive interventions following rapid discontinuation of prednisone in adult kidney transplant recipients.
Interventions
Cyclosporine and mycophenolate mofetil, high level tacrolimus (TAC,8-12µg/L) and low level sirolimus(SIR 3-7µg/L) or low level tacrolimus (3-7µg/L) and high level sirolimus (8-12µg/L).
Participants
440, first or second kidney transplant recipients.
Outcomes
The primary outcomes included: patient return to dialysis, patient survival (death with function), graft survival and retransplant of biopsy-proven chronic allograft nephropathy.
Follow-up
10 years.
CET Conclusions
This is a ten year follow up of a trial first reported in 2005 in which three immunosuppressive regimens all involving rapid discontinuation of steroids were compared. There was no difference in the rate of biopsy proven acute rejection or of chronic rejection. However there was a higher rate of new onset diabetes in the high dose tacrolimus group and high rates of anaemia in both arms involving sirolimus. Thus rapid discontinuation of steroids in these three immunosuppressive regimens produced similar results but it should be noted that induction of all patients was carried out with thymoglobulin and secondly that the majority of patients were recipients of a living related or unrelated donor kidney.
Data analysis
Available case analysis
Trial registration
Not reported.