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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 Jan 12, 2020

Vincenti F, et al. - In this study, researchers investigated various doses of the anti-CD40 monoclonal antibody bleselumab (ASKP1240) regarding their safety, tolerability, pharmacokinetics, and pharmacodynamics in de novo kidney transplant recipients receiving concomitant standard immunosuppression over 90 days posttransplant. Randomization of 50 kidney transplant recipients to receive bleselumab 50 mg, 100 mg, 200 mg, or 500 mg or placebo in addition to standard maintenance immunosuppression was done; 45 received their randomized treatment (bleselumab [n = 37] or placebo [n = 8]). Outcomes suggest bleselumab as safe at all doses; it exhibited nonlinear pharmacokinetics and dose-dependent prolonged B cell CD40 receptor occupancy.
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