Modeling graft loss in patients with donor-specific antibody at baseline using the Birmingham-Mayo (BirMay) predictor: Implications for clinical trials
Autor: | Manuel Moreno Gonzales, Patrick G. Dean, Keisha Bonner, Lynn D. Cornell, Carrie A. Schinstock, Alexandre Loupy, Walter D. Park, Carmen Lefaucheur, Richard Borrows, Andrew Bentall, Byron H. Smith, Mark D. Stegall |
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Rok vydání: | 2018 |
Předmět: |
Graft Rejection
Male medicine.medical_specialty Population 030230 surgery Graft loss Kidney Function Tests Risk Assessment Cohort Studies 03 medical and health sciences 0302 clinical medicine HLA Antigens Isoantibodies Risk Factors Internal medicine Immunology and Allergy Medicine Humans Pharmacology (medical) education Statistic Transplantation education.field_of_study Models Statistical business.industry Clinical study design Donor specific antibodies Incidence Graft Survival Middle Aged Allografts Prognosis Kidney Transplantation Tissue Donors United States body regions Clinical trial Survival Rate Histocompatibility Cohort Kidney Failure Chronic Female business Glomerular Filtration Rate |
Zdroj: | American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons. 19(8) |
ISSN: | 1600-6143 |
Popis: | 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. |
Databáze: | OpenAIRE |
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