Overcoming preexisting alloantibody in renal transplantation—improving outcomes while reducing needs and costs

Bentall, Andrew; Cohney, Solomon Shlomo J

doi:10.1111/ajt.14494

Cited by 1 publication

(2 citation statements)

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“…Several studies have demonstrated that kidney transplant recipients who have DSA at the time of transplantation have inferior outcomes to those without DSA . Clearly, new therapy is needed to overcome the immunologic hurdle of preformed DSA . However, determining the appropriate design of clinical trials in this area has been vexing.…”

Section: Introductionmentioning

confidence: 99%

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

Bentall

Smith

Gonzáles

et al. 2019

American Journal of Transplantation

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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 lowrisk 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. K E Y W O R D S alloantibody, clinical research/practice, kidney (allograft) function/dysfunction, kidney transplantation/nephrology, pathology/histopathology, protocol biopsy, risk assessment/risk stratification 1 | INTRODUC TI ON 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 treated (eg, studies design to treat antibody-mediated rejection [ABMR]) or as surrogate efficacy endpoints for trials aimed at improving long-term graft survival. Several studies have demonstrated that kidney transplant recipients who have DSA at the time of transplantation have inferior outcomes to those without DSA. 1-3 Clearly, new therapy is needed to overcome the immunologic hurdle of preformed

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Section: Introductionmentioning

confidence: 99%

“…DSA. 4 However, determining the appropriate design of clinical trials in this area has been vexing. Similar to the issue in low-risk populations is that only a relatively small subset of patients experience graft loss and the time to graft loss may be many years.…”

mentioning

confidence: 99%