A Study to Assess the Efficacy and Safety of ASKP1240 in de Novo Kidney Transplant Recipients
Status:
Completed
Trial end date:
2017-01-27
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate the efficacy and safety of ASKP1240, an anti-CD40
monoclonal antibody, for the prophylaxis of organ rejection after kidney transplantation.
This study will compare the efficacy of basiliximab induction, ASKP1240, mycophenolate
mofetil (MMF), and steroids [calcineurin inhibitor (CNI) avoidance] to the standard of care
immunosuppressive regimen (basiliximab induction + tacrolimus + MMF + steroids). In addition,
the study will compare the efficacy of basiliximab induction, ASKP1240, tacrolimus and
steroids [CNI minimization-MMF avoidance] to the standard of care immunosuppressive regimen
(basiliximab induction + tacrolimus + MMF + steroids).
Phase:
Phase 2
Details
Lead Sponsor:
Astellas Pharma Global Development, Inc.
Collaborators:
Kyowa Hakko Kirin Company, Limited Kyowa Kirin Co., Ltd.