Purpose: Long-term efficacy and safety of everolimus (EVR) based immunosuppression for de novo kidney transplant recipient who were involved in A1202 study from our institute was evaluated in clinical outcomes as well as donor specific antibody (DSA) production.

Methods: During March 2008 and August 2009, twenty-four recipients were prospectively randomized into two groups to compare clinical outcome of kidney transplantation between EVR based and mycophenolate mofetile (MMF) based immunosuppression. EVR group received reduced-exposure cyclosporine (CsA; target C0 25-50ng/ml after 6 months) + steroid, and EVR-C0 were adjusted 3-12ng/ml. MMF group received standard-exposure cyclosporine (CsA; target C0 100-250ng/ml after 6 months) + steroid. Both group received basiliximab induction.

Results: With a mean observation period of 7.0 (6.2-7.6) years, current patient and graft survival is 100% and 100% in EVR group and 100% and 90.9% in MMF group (EVR; n=13, MMF; n=11). Renal function expressed as eGFR was similar 40.5±12.8 in EVR group and 36.8±4.9ml/min/1.73m² in MMF group. Significant proteinuria, more than 300mg/day, were observed more in EVR group (77%) than in MMF group (54.5%) respectively, however the proteinuria in EVR group was successfully treated with angiotensin-II receptor blockade. Incidence of Cytomegalovirus (CMV) infection was significantly reduced to 15.1% in EVR group comparing to 46.2% in MMF group, especially none of seropositive recipients for CMV developed CMV infection under pre-emptive therapy principle. None of EVR and 9.1% of MMF group was treated for clinical T cell mediated rejection, similar incidence of Banff borderline change on protocol biopsies were observed in 7.7% of EVR group and 18.2% of MMF group 6 months after transplant. None of EVR group revealed peritubular capillaritis while 9.1% in MMF group developed chronic active antibody mediated rejection. Luminex solid phase assay revealed accumulative class II DSA production rate of 7.7% in EVR group and 27.3% in MMF group after 7 years after transplantation respectively.

Conclusions: EVR based immunosuppression provides even better clinical outcomes as well as the incidence of de novo DSA production compared with MMF based immunosuppression with 7 years follow-up.

CITATION INFORMATION: Watarai Y, Okada M, Futamura K, Nagai T, Yamamoto T, Tsujita M, Hiramitsu T, Goto N, Narumi S, Kobayashi T. Long-Term Efficacy and Safety of Everolimus Based Immunosuppression on De Novo Kidney Transplantation with 7 Years Follow-Up. Am J Transplant. 2016;16 (suppl 3).

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