Summary of FDA Antibody‐Mediated Rejection Workshop

• Published in: American journal of transplantation Vol. 11; no. 5; pp. 896 - 906
• Main Authors: Archdeacon, P., Chan, M., Neuland, C., Velidedeoglu, E., Meyer, J., Tracy, L., Cavaille‐Coll, M., Bala, S., Hernandez, A., Albrecht, R.
• Format: Journal Article Conference Proceeding
• Language: English
• Published: Malden, USA Blackwell Publishing Inc 01.05.2011
• Subjects: Animals; Antibodies - therapeutic use; Antibody‐mediated rejection; clinical trials; Clinical Trials as Topic; evidence‐based medicine; Graft Rejection; HLA Antigens - chemistry; Humans; Models, Animal; Organ Transplantation - methods; Prognosis; regulatory issues; Research Design; Risk; surrogate endpoints; transplantation research; Treatment Outcome; United States; United States Food and Drug Administration
• ISSN: 1600-6135; 1600-6143
• DOI: 10.1111/j.1600-6143.2011.03525.x

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. In this meeting report, authors from the FDA summarize the discussions held at the FDA public workshop in June 2010 regarding both the state of the science and considerations for future clinical trials related to antibody‐mediated rejection. See editorial by Woodle and Gebel on page 880.