A randomized, phase 1b study of the pharmacokinetics, pharmacodynamics, safety, and tolerability of bleselumab, a fully human, anti-CD40 monoclonal antibody, in kidney transplantation
American Journal of Transplantation Aug 14, 2019
Vincenti F, et al. - In de novo kidney transplant recipients receiving concomitant standard immunosuppression over 90 days posttransplant, safety, tolerability, pharmacokinetics, and pharmacodynamics of various doses of the anti-CD40 monoclonal antibody bleselumab were examined. Researchers randomly assigned 50 transplant recipients (1:1:1:1:1) to receive bleselumab 50 mg, 100 mg, 200 mg, or 500 mg, or placebo, in addition to standard maintenance immunosuppression. Their randomized treatment was received by 45 patients (bleselumab [n = 37] or placebo [n = 8]). In the range of 50–500 mg, they observed a more than dose-proportional increase in AUCinf and AUClast; a linear increase in Cmax with increasing dose was observed. Bleselumab showed dose-dependent prolonged B-cell CD40 receptor occupancy and was well tolerated at all doses.
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