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A Randomized Trial Comparing Imlifidase to Plasmapheresis in Kidney Transplant Recipients With Antibody-Mediated Rejection

dc.rights.licenseopenen_US
dc.contributor.authorHALLECK, Fabian
dc.contributor.authorBÖHMIG, Georg A.
hal.structure.identifierImmunology from Concept and Experiments to Translation = Immunologie Conceptuelle, Expérimentale et Translationnelle [ImmunoConcept]
dc.contributor.authorCOUZI, Lionel
dc.contributor.authorROSTAING, Lionel
dc.contributor.authorEINECKE, Gunilla
dc.contributor.authorLEFAUCHEUR, Carmen
dc.contributor.authorLEGENDRE, Christophe
dc.contributor.authorMONTGOMERY, Robert
dc.contributor.authorHUGHES, Peter
dc.contributor.authorCHANDRAKER, Anil
dc.contributor.authorWYBURN, Kate
dc.contributor.authorHALLORAN, Phil
dc.contributor.authorMALDONADO, Angela Q.
dc.contributor.authorSJÖHOLM, Kristoffer
dc.contributor.authorRUNSTRÖM, Anna
dc.contributor.authorLEFEVRE, Paola
dc.contributor.authorTOLLEMAR, Jan
dc.contributor.authorJORDAN, Stanley
dc.date.accessioned2024-11-06T10:45:59Z
dc.date.available2024-11-06T10:45:59Z
dc.date.issued2024-07
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/203141
dc.description.abstractEnBackground: Antibody-mediated rejection (ABMR) poses a barrier to long-term graft survival and is one of the most challenging events after kidney transplantation. Removing donor specific antibodies (DSA) through therapeutic plasma exchange (PLEX) is a cornerstone of antibody depletion but has inconsistent effects. Imlifidase is a treatment currently utilized for desensitization with near-complete inactivation of DSA both in the intra- and extravascular space. Methods: This was a 6-month, randomized, open-label, multicenter, multinational trial conducted at 14 transplant centers. Thirty patients were randomized to either imlifidase or PLEX treatment. The primary endpoint was reduction in DSA level during the 5 days following the start of treatment. Results: Despite considerable heterogeneity in the trial population, DSA reduction as defined by the primary endpoint was 97% for imlifidase compared to 42% for PLEX. Additionally, imlifidase reduced DSA to noncomplement fixing levels, whereas PLEX failed to do so. After antibody rebound in the imlifidase arm (circa days 6–12), both arms had similar reductions in DSA. Five allograft losses occurred during the 6 months following the start of ABMR treatment—four within the imlifidase arm (18 patients treated) and one in the PLEX arm (10 patients treated). In terms of clinical efficacy, the Kaplan–Meier estimated graft survival was 78% for imlifidase and 89% for PLEX, with a slightly higher eGFR in the PLEX arm at the end of the trial. The observed adverse events in the trial were as expected, and there were no apparent differences between the arms. Conclusion: Imlifidase was safe and well-tolerated in the ABMR population. Despite meeting the primary endpoint of maximum DSA reduction compared to PLEX, the trial was unsuccessful in demonstrating a clinical benefit of imlifidase in this heterogenous ABMR population. Trial Registration: EudraCT number: 2018-000022-66, 2020-004777-49; ClinicalTrials.gov identifier: NCT03897205, NCT04711850.
dc.language.isoENen_US
dc.rightsAttribution-NonCommercial-NoDerivs 3.0 United States*
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/3.0/us/*
dc.subject.enImmunosuppressant
dc.subject.enKidney (allograft) function/dysfunction
dc.subject.enPlasmapheresis/plasma exchange
dc.subject.enRejection: antibody-mediated (ABMR)
dc.title.enA Randomized Trial Comparing Imlifidase to Plasmapheresis in Kidney Transplant Recipients With Antibody-Mediated Rejection
dc.typeArticle de revueen_US
dc.identifier.doi10.1111/ctr.15383en_US
dc.subject.halSciences du Vivant [q-bio]/Immunologieen_US
dc.identifier.pubmed39023092en_US
bordeaux.journalClinical Transplantationen_US
bordeaux.volume38en_US
bordeaux.hal.laboratoriesImmunoConcEpT - UMR 5164en_US
bordeaux.issue7en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionCNRSen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.identifierhal-04769264
hal.version1
hal.date.transferred2024-11-06T10:46:03Z
hal.popularnonen_US
hal.audienceInternationaleen_US
hal.exporttrue
dc.rights.ccCC BY-NC-NDen_US
bordeaux.COinSctx_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.jtitle=Clinical%20Transplantation&rft.date=2024-07&rft.volume=38&rft.issue=7&rft.au=HALLECK,%20Fabian&B%C3%96HMIG,%20Georg%20A.&COUZI,%20Lionel&ROSTAING,%20Lionel&EINECKE,%20Gunilla&rft.genre=article


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