title: Summary of FDA antibody-mediated rejection workshop.
abstract: 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.
authors.affiliation: Division of Special Pathogen and Transplant Products, Office of Antimicrobial Products, Center for Drug Evaluation and Research, FDA, Silver Spring, MD, USA.
authors.forename: P
authors.initials: P
authors.lastname: Archdeacon
authors.forename: M
authors.initials: M
authors.lastname: Chan
authors.forename: C
authors.initials: C
authors.lastname: Neuland
authors.forename: E
authors.initials: E
authors.lastname: Velidedeoglu
authors.forename: J
authors.initials: J
authors.lastname: Meyer
authors.forename: L
authors.initials: L
authors.lastname: Tracy
authors.forename: M
authors.initials: M
authors.lastname: Cavaille-Coll
authors.forename: S
authors.initials: S
authors.lastname: Bala
authors.forename: A
authors.initials: A
authors.lastname: Hernandez
authors.forename: R
authors.initials: R
authors.lastname: Albrecht
mesh_terms: D000818:Animals; D000906:Antibodies / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D006084:Graft Rejection; D006680:HLA Antigens / Q000737:chemistry; D006801:Humans; D023421:Models, Animal; D016377:Organ Transplantation / Q000379:methods*; D011379:Prognosis; D012107:Research Design; D012306:Risk; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000906:Antibodies; D006680:HLA Antigens