A Study to Assess Pharmacokinetic, Pharmacodynamic, Safety and Tolerability of ASKP1240 in de Novo Kidney Transplantation

Phase 1 Completed 50 enrolled Astellas Pharma Inc Kyowa Kirin, Inc. · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of the study is to assess the Pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of ASKP1240 when administered to subjects who received a de novo kidney transplant.

Timeline

Start: 2010-11-17
Primary completion: 2012-01-23
Completion: 2012-01-23

Publications

Vincenti F, Klintmalm G, Yang H, Ram Peddi V, Blahunka P, Conkle A, Santos V, Holman J. A randomized, phase 1b study of the pharmacokinetics, pharmacodynamics, safety, and tolerability of bleselumab, a fully human, anti-CD40 monoclonal antibody, in kidney transplantation. Am J Transplant. 2020 Jan;20(1):172-180. doi: 10.1111/ajt.15560. Epub 2019 Sep 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	bleselumab	Monoclonal antibody	50 mg	Intravenous
Subject	bleselumab	Monoclonal antibody	100 mg	Intravenous
Subject	bleselumab	Monoclonal antibody	200 mg	Intravenous
Subject	bleselumab	Monoclonal antibody	500 mg	Intravenous

Indications

No indication recorded.