Summary of FDA Antibody-Mediated Rejection Workshop

被引：139

作者：

Archdeacon, P. ^{[1
]}

Chan, M. ^{[2
]}

Neuland, C. ^{[3
]}

Velidedeoglu, E. ^{[1
]}

Meyer, J. ^{[1
]}

Tracy, L. ^{[4
]}

Cavaille-Coll, M. ^{[1
]}

Bala, S. ^{[1
]}

Hernandez, A. ^{[1
]}

Albrecht, R. ^{[1
]}

机构：

[1] US FDA, Div Special Pathogen & Transplant Prod, Off Antimicrobial Prod, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA

[2] US FDA, Div Immunol & Hematol Devices, Off Vitro Diagnost Devices Evaluat & Safety, Ctr Devices & Radiol Hlth, Silver Spring, MD USA

[3] US FDA, Gastroenterol & Renal Devices Branch, Div Reprod Abdominal & Radiol Devices, Off Device Evaluat,Ctr Devices & Radiol Hlth, Silver Spring, MD USA

[4] US FDA, Div Biometr 7, Off Biostat, Ctr Drug Evaluat & Res, Silver Spring, MD USA

来源：

AMERICAN JOURNAL OF TRANSPLANTATION | 2011年 / 11卷 / 05期

关键词：

Antibody-mediated rejection; clinical trials; evidence-based medicine; regulatory issues; surrogate endpoints; transplantation research; ACUTE HUMORAL REJECTION; DONOR-SPECIFIC ANTIBODIES; HUMAN-LEUKOCYTE ANTIGEN; POSITIVE CROSS-MATCH; ALLOGRAFT RECIPIENTS; CLINICAL-RELEVANCE; RENAL-ALLOGRAFTS; THERAPY; PLASMAPHERESIS; RESCUE;

D O I：

10.1111/j.1600-6143.2011.03525.x

中图分类号：

R61 [外科手术学];

学科分类号：

摘要：

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.

引用

页码：896 / 906

页数：11

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