1. Results of a multicenter prospective clinical study in Japan for evaluating efficacy and safety of desensitization protocol based on rituximab in ABO-incompatible kidney transplantation
- Author
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Kazuhide Saito, Norio Yoshimura, Atsushi Aikawa, Kazunari Tanabe, Takashi Yagisawa, Kota Takahashi, Shohei Fuchinoue, Shiro Takahara, Motohide Shimazu, Yoshihiko Watarai, and Kunio Morozumi
- Subjects
Graft Rejection ,Male ,Nephrology ,Time Factors ,Physiology ,Basiliximab ,medicine.medical_treatment ,030232 urology & nephrology ,030230 surgery ,0302 clinical medicine ,Japan ,HLA Antigens ,Isoantibodies ,Risk Factors ,hemic and lymphatic diseases ,Prospective Studies ,Kidney transplantation ,Graft Survival ,Immunosuppression ,Middle Aged ,Treatment Outcome ,Blood Group Incompatibility ,Histocompatibility ,Drug Therapy, Combination ,Female ,Rituximab ,Immunosuppressive Agents ,medicine.drug ,Adult ,medicine.medical_specialty ,Adolescent ,Drug Administration Schedule ,ABO Blood-Group System ,Young Adult ,03 medical and health sciences ,Physiology (medical) ,Internal medicine ,medicine ,Humans ,Organ donation ,Aged ,business.industry ,Ciclosporin ,medicine.disease ,Kidney Transplantation ,Surgery ,Transplantation ,Desensitization, Immunologic ,business - Abstract
Deceased organ donations are rare in Japan, with most kidney transplants performed from a limited number of living donors. Researchers have thus developed highly successful ABO-incompatible transplantation procedures, emphasizing preoperative desensitization and postoperative immunosuppression. A recent open-label, single-arm, multicenter clinical study prospectively examined the efficacy and safety of rituximab/mycophenolate mofetil desensitization in ABO-incompatible kidney transplantation without splenectomy. Mycophenolate mofetil and low dose steroid were started 28 days pretransplant, followed by two doses of rituximab 375 mg/m2 at day −14 and day −1, and postoperative immunosuppression with tacrolimus or ciclosporin and basiliximab. The primary endpoint was the non-occurrence rate of acute antibody-mediated rejection. Patient survival and graft survival were monitored for 1 year posttransplant. Eighteen patients received rituximab and underwent ABO-incompatible kidney transplantation. CD19-positive peripheral B cell count decreased rapidly after the first rituximab infusion and recovered gradually after week 36. The desensitization protocol was tolerable, and most rituximab-related infusion reactions were mild. No anti-A/B antibody-mediated rejection occurred with this series. One patient developed anti-HLA antibody-mediated rejection (Banff 07 type II) on day 2, which was successfully managed. Patient and graft survival were both 100 % after 1 year. Our desensitization protocol was confirmed to be clinically effective and with acceptable toxicities for ABO-I-KTx (University Hospital Medical Information Network Registration Number: UMIN000006635).
- Published
- 2016