Summary of FDA antibody-mediated rejection workshop.

Published

Conference Paper

The Food and Drug Administration (FDA) held an open public workshop in June 2010 to discuss the current state of science related to antibody-mediated rejection (AMR) in kidney transplantation. Desensitization, acute AMR and chronic AMR (CAMR) were considered in the context of clinical trial design. Participants discussed experiences with HLA antibody detection and quantitation and the utility of monitoring donor-specific antibodies (DSAs) to inform the management of patients with AMR. The role for animal models was discussed. Diagnostic and prognostic features of histology were presented, followed by discussion of sensitivity and specificity of various criteria. The published literature on treatment of acute AMR was summarized, which consisted of case series and limited data from controlled clinical trials. Considerations for future clinical trials were presented, including endpoints and statistical evaluations of outcome. Although many issues need further consideration, the meeting enabled an important exchange of ideas between experts in the field.

Full Text

Duke Authors

Cited Authors

  • Archdeacon, P; Chan, M; Neuland, C; Velidedeoglu, E; Meyer, J; Tracy, L; Cavaille-Coll, M; Bala, S; Hernandez, A; Albrecht, R

Published Date

  • May 2011

Published In

Volume / Issue

  • 11 / 5

Start / End Page

  • 896 - 906

PubMed ID

  • 21521465

Pubmed Central ID

  • 21521465

Electronic International Standard Serial Number (EISSN)

  • 1600-6143

International Standard Serial Number (ISSN)

  • 1600-6135

Digital Object Identifier (DOI)

  • 10.1111/j.1600-6143.2011.03525.x