Roufosse, Candice, Becker, Jan Ulrich, Rabant, Marion ORCID: 0000-0001-5696-6478, Seron, Daniel, Bellini, Maria Irene ORCID: 0000-0003-0730-4923, Boehmig, Georg A., Budde, Klemens ORCID: 0000-0002-7929-5942, Diekmann, Fritz, Glotz, Denis, Hilbrands, Luuk ORCID: 0000-0002-4935-9765, Loupy, Alexandre, Oberbauer, Rainer, Pengel, Liset, Schneeberger, Stefan and Naesens, Maarten (2022). Proposed Definitions of Antibody-Mediated Rejection for Use as a Clinical Trial Endpoint in Kidney Transplantation. Transpl. Int., 35. LAUSANNE: FRONTIERS MEDIA SA. ISSN 1432-2277

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Abstract

Antibody-mediated rejection (AMR) is caused by antibodies that recognize donor human leukocyte antigen (HLA) or other targets. As knowledge of AMR pathophysiology has increased, a combination of factors is necessary to confirm the diagnosis and phenotype. However, frequent modifications to the AMR definition have made it difficult to compare data and evaluate associations between AMR and graft outcome. The present paper was developed following a Broad Scientific Advice request from the European Society for Organ Transplantation (ESOT) to the European Medicines Agency (EMA), which explored whether updating guidelines on clinical trial endpoints would encourage innovations in kidney transplantation research. ESOT considers that an AMR diagnosis must be based on a combination of histopathological factors and presence of donor-specific HLA antibodies in the recipient. Evidence for associations between individual features of AMR and impaired graft outcome is noted for microvascular inflammation scores >= 2 and glomerular basement membrane splitting of > 10% of the entire tuft in the most severely affected glomerulus. Together, these should form the basis for AMR-related endpoints in clinical trials of kidney transplantation, although modifications and restrictions to the Banff diagnostic definition of AMR are proposed for this purpose. The EMA provided recommendations based on this Broad Scientific Advice request in December 2020; further discussion, and consensus on the restricted definition of the AMR endpoint, is required.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Roufosse, CandiceUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Becker, Jan UlrichUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rabant, MarionUNSPECIFIEDorcid.org/0000-0001-5696-6478UNSPECIFIED
Seron, DanielUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bellini, Maria IreneUNSPECIFIEDorcid.org/0000-0003-0730-4923UNSPECIFIED
Boehmig, Georg A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Budde, KlemensUNSPECIFIEDorcid.org/0000-0002-7929-5942UNSPECIFIED
Diekmann, FritzUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Glotz, DenisUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hilbrands, LuukUNSPECIFIEDorcid.org/0000-0002-4935-9765UNSPECIFIED
Loupy, AlexandreUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Oberbauer, RainerUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pengel, LisetUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schneeberger, StefanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Naesens, MaartenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-695419
DOI: 10.3389/ti.2022.10140
Journal or Publication Title: Transpl. Int.
Volume: 35
Date: 2022
Publisher: FRONTIERS MEDIA SA
Place of Publication: LAUSANNE
ISSN: 1432-2277
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
DONOR-SPECIFIC ANTIBODIES; NOVO THROMBOTIC MICROANGIOPATHY; RENAL-ALLOGRAFT BIOPSIES; EARLY PROTOCOL BIOPSIES; MICROCIRCULATION INFLAMMATION; MICROVASCULAR INFLAMMATION; WORKING CLASSIFICATION; ELECTRON-MICROSCOPY; HUMORAL REJECTION; C4D DEPOSITIONMultiple languages
Surgery; TransplantationMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/69541

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