Purpose: The impact of everolimus (EVR) based immunosuppression in De Novo Kidney Transplantation was evaluated in clinical outcomes, protocol biopsies findings and donor specific antibody (DSA) production.
Methods: During March 2008 and August 2009, twenty-six recipients were enrolled to compare the safety and efficacy 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 49 (49-57) months, current patient and graft survival is 100% in both groups (EVR; n=13, MMF; n=13). Renal function expressed as eGFR was similar 41.6±14.3 in EVR group and 37.2±7.0 in MMF group. Significant proteinuria, more than 300mg/day, were observed more in EVR group (69%) than in MMF group (27%) 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. Protocol oral glucose tolerance test at 6 and 12 months revealed more, but no significantly, worsen profile in 46% of EVR group to 18% in MMF group. None of EVR and 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 15.4% of MMF group, but none of both groups revealed peritubular capillaritis. Luminex solid phase assay revealed the similar incidence of class II DSA production in both groups, 7.7% of EVR group at 2 years after transplant and 15.4% of MMF group at 3 years.
Conclusions: EVR based immunosuppression provides equivalent clinical outcomes as well as the incidence of De Novo DSA production with MMF based immunosuppression with 4 years follow-up.
To cite this abstract in AMA style:Narumi S, Watarai Y, Yamamoto T, Tsujita M, Hiramitsu T, Nanmoku K, Goto N, Katayama A, Takeda A, Morozumi K, Uchida K, Kobayashi T. Efficacy and Safety of Everolimus Based Immunosuppression on De Novo Kidney Transplantation with 4 Years Follow-Up Especially in Protocol Biopsy Findings and Donor Specific Antibody Production [abstract]. Am J Transplant. 2013; 13 (suppl 5). https://atcmeetingabstracts.com/abstract/efficacy-and-safety-of-everolimus-based-immunosuppression-on-de-novo-kidney-transplantation-with-4-years-follow-up-especially-in-protocol-biopsy-findings-and-donor-specific-antibody-production/. Accessed May 7, 2021.
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