Long-Term Efficacy and Safety of Everolimus Based Immunosuppression on De Novo Kidney Transplantation with 10 Years Follow-Up

Y. Watarai¹, S. Narumi¹, T. Tomosugi¹, K. Futamura², M. Okada¹, M. Tsujita², T. Hiramitsu¹, T. Kobayashi³, N. Goto²

¹Transplant Surgery, Nagoya Daini Red Cross Hospital, Nagoya, Japan, ²Transplant Nephrology, Nagoya Daini Red Cross Hospital, Nagoya, Japan, ³Kidney Transplantation, Aichi Medical University, Nagoya, Japan

Meeting: 2019 American Transplant Congress

Abstract number: A228

Keywords: Alloantibodies, Cytomeglovirus, Graft survival, Kidney transplantation

Session Information

Session Name: Poster Session A: Kidney Immunosuppression: Novel Regimens and Drug Minimization

Session Type: Poster Session

Date: Saturday, June 1, 2019

Session Time: 5:30pm-7:30pm

Presentation Time: 5:30pm-7:30pm

Location: Hall C & D

*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 protocol biopsies findings and donor specific antibody (DSA) production.

*Methods: During March 2008 and August 2009, twenty-four recipients 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 3-8ng/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 10.0 (9.2-10.6) years, current patient and graft survival is 100% in EVR group and 80.8% in MMF group (EVR; n=13, MMF; n=11). Renal function expressed as eGFR was similar 41.2±13.8 in EVR group and 33.4±18.0ml/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 6 or 12 months protocol biopsies were observed in 7.7% of EVR group and 18.2% of MMF group. 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 0% in EVR group and 18.2% in MMF group (P=0.11) after 10 years after transplant respectively.

*Conclusions: EVR based immunosuppression provides equivalent or even better clinical outcomes as well as the incidence of de novo DSA production with MMF based immunosuppression with 10 years follow-up.

To cite this abstract in AMA style:

Watarai Y, Narumi S, Tomosugi T, Futamura K, Okada M, Tsujita M, Hiramitsu T, Kobayashi T, Goto N. Long-Term Efficacy and Safety of Everolimus Based Immunosuppression on De Novo Kidney Transplantation with 10 Years Follow-Up [abstract]. Am J Transplant. 2019; 19 (suppl 3). https://atcmeetingabstracts.com/abstract/long-term-efficacy-and-safety-of-everolimus-based-immunosuppression-on-de-novo-kidney-transplantation-with-10-years-follow-up/. Accessed May 18, 2025.

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