Date: Monday, May 4, 2015
Session Time: 5:30pm-6:30pm
Presentation Time: 5:30pm-6:30pm
Location: Exhibit Hall E
Purpose: An open-label, single arm, multicenter clinical study has been conducted in Japan for prospective examination of the efficacy and safety of desensitization protocol with rituximab(RTX)/MMF in ABO-incompatible kidney transplantation (ABOi-KT) without splenectomy (UMIN000006635).
Methods: For pre-operative desensitization, pts received MMF and low-dose glucocorticoid started on day -28 and two doses of RTX with 375 mg/m2 at day -14 and day -1. For post-operative immunosuppression, tacrolimus or ciclosporin started on day -2 or day -1 respectively and basiliximab administrated twice on day 0 and day 4. Primary endpoint was the rate of patient with free from acute antibody-mediated rejection(AMR) resulting from anti-A/B antibody. Pts were followed for 1 year after transplantation for survival.
Results: A total of 20 patients(pts) were enrolled in the study, 18 of which received ABOi-KT and completed the study. CD19/20 positive peripheral B cells rapidly decreased immediately after 1st infusion of RTX and had gradually recovered since 36 weeks. Pre-transplant desensitization protocol was tolerable and most infusion reactions related to RTX were mild in severity. A total of 16 infections observed during the study and 5 of which were grade 3. No patient developed AMR resulting from anti-A/B antibody, which was confirmed by central pathologic review using biopsy specimen collected 4 weeks after transplantation. However 1 pt developed anti-HLA antibody related AMR(Banff 07 type II)on day 2. This patient was cross match negative at screening but revealed donor specific anti-HLA antibody positive by post-hoc flow-PRA using pre-operative storage sample and was successfully treated with steroid pulse, gusperimus and plasmapheresis. One-year pts and graft survival were both 100%.
To cite this abstract in AMA style:Takahashi K, Saito K, Takahara S, Fuchinoue S, Yagisawa T, Aikawa A, Watarai Y, Yoshimura N, Tanabe K, Morozumi K, Shimazu M. Efficacy and Safety of Desensitization Protocol Based On Rituximab Plus MMF in ABO-Incompatible Kidney Transplantation Without Splenectomy [abstract]. Am J Transplant. 2015; 15 (suppl 3). https://atcmeetingabstracts.com/abstract/efficacy-and-safety-of-desensitization-protocol-based-on-rituximab-plus-mmf-in-abo-incompatible-kidney-transplantation-without-splenectomy/. Accessed July 22, 2018.
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