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Am J Transplant. 2019 Aug;19(8):2274-2283. doi: 10.1111/ajt.15312. Epub 2019 Mar 13.

Modeling graft loss in patients with donor-specific antibody at baseline using the Birmingham-Mayo (BirMay) predictor: Implications for clinical trials.

Author information

1
Department of Renal Medicine, Queen Elizabeth Hospital Birmingham, Birmingham, UK.
2
William J. von Liebig Transplant Center, Mayo Clinic, Rochester, Minnesota.
3
Servicio de Cirugía General, Americana, Lima, Perú.
4
Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN.
5
Department of Nephrology and Kidney Transplantation, Saint-Louis Hospital, Assistance Publique - Hôpitaux de Paris, Paris, France.
6
Department of Nephrology-Transplantation Necker Hospital, Assistance Publique-Hôpitaux de Paris, University Paris Descartes, Paris, France.
7
Paris Cardiovascular Research Centre - Biostatistics Unit University Paris Descartes, UMR-S970, Paris, France.

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

PMID:
30768833
DOI:
10.1111/ajt.15312

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