Transplant Trial Watch

Outcome of Sirolimus based Immunosuppression, Fifteen Years Post Live-Donor Kidney Transplantation: Single Center Experience.

Hamdy AF, Elhadedy MA, et al.

Clin Transplant. 2018; [record in progress].

An observational extension study of an RCT to assess the long term effects of sirolimus based immunosuppression in live donor kidney transplant recipients on survival and graft function.

Live donor kidney transplant recipients were randomized to receive sirolimus primary immunosuppression in combination with either low dose tacrolimus (TAC group) or mycophenolate mofetil (MMF group).

132 adult (TAC group, n=65; MMF group, n=67) patients with end-stage renal disease, who received a live donor kidney allo-transplant.

Study outcomes were efficacy (patient and graft survival, biopsy-confirmed acute rejection, chronic allograft nephropathy episodes and graft function), safety and renal allograft pathology. Changes to immunosuppression doses and regimens were also assessed.

15 years post transplantation.

CET Conclusions
This manuscript reports the 15-year follow-up of a randomized trial comparing two sirolimus-based regimens in living donor renal transplant recipients. Patients were randomized to sirolimus, steroids and either low-dose tacrolimus or MMF. This long-term follow-up demonstrates numerically higher mortality in the Tac arm (10.8% vs. 3%), along with significantly inferior graft function. There was no difference in graft survival, adverse events or tolerability between the arms. Perhaps as expected, avoiding tacrolimus does appear to offer some benefit in renal function in the long term, and the combination of MMF and sirolimus provides acceptable outcomes in this low-risk population. However, it should be noted that over 40% patients in both arms switched to a non-mTOR regimen during the course of follow-up, in keeping with previous evidence.

Jadad score

Data analysis
Modified intention-to-treat analysis

Allocation concealment

Quality notes
SCORE BASED ON ‒ Hamdy AF, El-Agroudy AE, Bakr MA, et al. Am J Transplant. 2005; 5:2531-8.

Trial registration

Funding source
Non-industry funded