title: Rational clinical trial design for antibody mediated renal allograft injury.
abstract: Antibody mediated renal allograft rejection is a significant cause of acute and chronic graft loss. Recent work has revealed that AMR is a complex processes, involving B and plasma cells, donor-specific antibodies, complement, vascular endothelial cells, NK cells, Fc receptors, cytokines and chemokines. These insights have led to the development of numerous new therapies, and adaptation of others originally developed for treatment of hemetologic malignancies, autoimmune and complement mediated conditions. Here we review emerging insights into the pathophysiology of AMR as well as current and emerging therapies for both acute and chronic AMR. Finally, we discuss rational clinical trial design in light of antibody and B cell immunobiology, as well as appropriate efficacy metrics to identify robust protocols and therapeutic agents.
authors.affiliation: University of Rochester.
authors.forename: Shaifali
authors.initials: S
authors.lastname: Sandal
authors.affiliation: University of Rochester.
authors.forename: Martin S
authors.initials: MS
authors.lastname: Zand
mesh_terms: D000906:Antibodies / Q000276:immunology* / Q000302:isolation & purification; D001402:B-Lymphocytes / Q000276:immunology; D002469:Cell Separation; D002986:Clinical Trials as Topic; D003165:Complement System Proteins / Q000276:immunology; D006084:Graft Rejection / Q000276:immunology / Q000517:prevention & control*; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000627:therapeutic use; D016030:Kidney Transplantation; D008213:Lymphocyte Activation; D012107:Research Design
chemical_list: D000906:Antibodies; D016756:Immunoglobulins, Intravenous; D003165:Complement System Proteins