@article{0c0091ff41a84641af838bf62fc26581,
title = "Modeling graft loss in patients with donor-specific antibody at baseline using the Birmingham-Mayo (BirMay) predictor: Implications for clinical trials",
abstract = "Predicting which renal allografts will fail and the likely cause of failure is important in clinical trial design to either enrich patient populations to be or as surrogate efficacy endpoints for trials aimed at improving long-term graft survival. This study tests our previous Birmingham-Mayo model (termed the BirMay Predictor) developed in a low-risk kidney transplant population in order to predict the outcome of patients with donor specific alloantibody (DSA) at the time of transplantation and identify new factors to improve graft loss prediction in DSA+ patients. We wanted define ways to enrich the population for future therapeutic intervention trials. The discovery set included 147 patients from Mayo Cohort and the validation set included 111 patients from the Paris Cohort—all of whom had DSA at the time of transplantation. The BirMay predictor performed well predicting 5-year outcome well in DSA+ patients (Mayo C statistic = 0.784 and Paris C statistic = 0.860). Developing a new model did not improve on this performance. A high negative predictive value of greater than 90% in both cohorts excluded allografts not destined to fail within 5 years. We conclude that graft-survival models including histology predict graft loss well, both in DSA+ cohorts as well as DSA- patients.",
keywords = "alloantibody, clinical research/practice, kidney (allograft) function/dysfunction, kidney transplantation/nephrology, pathology/histopathology, protocol biopsy, risk assessment/risk stratification",
author = "Andrew Bentall and Smith, {Byron H.} and Gonzales, {Manuel Moreno} and Keisha Bonner and Park, {Walter D.} and Cornell, {Lynn D.} and Dean, {Patrick G.} and Schinstock, {Carrie A.} and Richard Borrows and Carmen Lefaucheur and Alexandre Loupy and Stegall, {Mark D.}",
note = "Funding Information: AB was funded by a National Institute for Health Research (Clinical Lecturership award). This article presents independent research funded by the National Institute for Health Research (NIHR). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR, or the Department of Health. This publica‐ tion was made possible by CTSA Grant Number KL2 TR002379 from the National Center for Advancing Translational Sciences (NCATS), a component of the National Institutes of Health (NIH). Its contents are solely the responsibility of the authors and do not necessarily represent the official view of NIH. Funding Information: AB was funded by a National Institute for Health Research (Clinical Lecturership award). This article presents independent research funded by the National Institute for Health Research (NIHR). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR, or the Department of Health. This publication was made possible by CTSA Grant Number KL2 TR002379 from the National Center for Advancing Translational Sciences (NCATS), a component of the National Institutes of Health (NIH). Its contents are solely the responsibility of the authors and do not necessarily represent the official view of NIH. Publisher Copyright: {\textcopyright} 2019 The American Society of Transplantation and the American Society of Transplant Surgeons",
year = "2019",
month = aug,
doi = "10.1111/ajt.15312",
language = "English (US)",
volume = "19",
pages = "2274--2283",
journal = "American Journal of Transplantation",
issn = "1600-6135",
publisher = "Wiley-Blackwell",
number = "8",
}