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Safety and efficacy of eculizumab for the prevention of antibody-mediated rejection after deceased-donor kidney transplantation in patients with preformed donor-specific antibodies
INSERM, Paris Translat Res Ctr Organ Transplantat, Unite Mixte Rech S970, Paris, France;St Louis Hosp, AP HP, INSERM, Dept Nephrol & Organ Transplantat,Unite U1160, Paris, France.
Royal Adelaide Hosp, Cent & Northern Adelaide Renal & Transplantat Ser, Adelaide, SA, Australia;Univ Adelaide, Adelaide, SA, Australia.
Rangueil Univ Hosp Ctr, Dept Nephrol & Organ Transplantat, Toulouse, France;Grenoble Alpes Univ Hosp Ctr, Dept Nephrol Hemodialysis Apheresis & Transplanta, Ave Maquis du Gresivaudan, La Tronche, France.
Univ Paris 05, Hop Necker Enfants Malad, Sorbonne Paris Cite, Adult Nephrol Transplantat Serv, Paris, France;Hop Necker Enfants Malad, INSERM, Inst Necker Enfants Malad, U1151, Paris, France.
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2019 (English)In: American Journal of Transplantation, ISSN 1600-6135, E-ISSN 1600-6143, Vol. 19, no 10, p. 2865-2875Article in journal (Refereed) Published
Abstract [en]

The presence of preformed donor-specific antibodies in transplant recipients increases the risk of acute antibody-mediated rejection (AMR). Results of an open-label single-arm trial to evaluate the safety and efficacy of eculizumab in preventing acute AMR in recipients of deceased-donor kidney transplants with preformed donor-specific antibodies are reported. Participants received eculizumab as follows: 1200 mg immediately before reperfusion; 900 mg on posttransplant days 1, 7, 14, 21, and 28; and 1200 mg at weeks 5, 7, and 9. All patients received thymoglobulin induction therapy and standard maintenance immunosuppression including steroids. The primary end point was treatment failure rate, a composite of biopsy-proved grade II/III AMR (Banff 2007 criteria), graft loss, death, or loss to follow-up, within 9 weeks posttransplant. Eighty patients received transplants (48 women); the median age was 52 years (range 24-70 years). Observed treatment failure rate (8.8%) was significantly lower than expected for standard care (40%; P < .001). By 9 weeks, 3 of 80 patients had experienced AMR, and 4 of 80 had experienced graft loss. At 36 months, graft and patient survival rates were 83.4% and 91.5%, respectively. Eculizumab was well tolerated and no new safety concerns were identified. Eculizumab has the potential to provide prophylaxis against injury caused by acute AMR in such patients (EudraCT 2010-019631-35).

Place, publisher, year, edition, pages
WILEY , 2019. Vol. 19, no 10, p. 2865-2875
Keywords [en]
clinical research, practice, complement biology, donors and donation, deceased, immunosuppressant-fusion proteins and monoclonal antibodies, kidney transplantation, nephrology, rejection, antibody-mediated (ABMR), sensitization
National Category
Surgery
Identifiers
URN: urn:nbn:se:uu:diva-395726DOI: 10.1111/ajt.15397ISI: 000487782000024PubMedID: 31012541OAI: oai:DiVA.org:uu-395726DiVA, id: diva2:1365281
Available from: 2019-10-24 Created: 2019-10-24 Last updated: 2019-10-24Bibliographically approved

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