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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Global Development, Inc.
• Collaborators: Kyowa Hakko Kirin Company, Limited; Kyowa Kirin Co., Ltd.
• Treatments: Basiliximab; Mycophenolate mofetil; Mycophenolic Acid; Prednisone; Tacrolimus

Criteria

Inclusion Criteria:

• Subject is a recipient of a de novo kidney from a living or deceased donor

Exclusion Criteria:

• Subject has induction therapy, other than study-assigned basiliximab, planned as part of initial immunosuppressive regimen

• Subject has previously received or is receiving an organ transplant other than a kidney

• Subject will receive a solitary kidney from a deceased donor < 5 years of age

• Subject will receive a kidney with an anticipated cold ischemia time (CIT) of > 30 hours

• Subject will receive a kidney that meets both Extended Criteria Donor (ECD) and Donation after Cardiac Death (DCD) criteria. Note: a kidney that meets either ECD or DCD criteria is eligible for inclusion

• Subject will receive an ABO incompatible donor kidney

• Subject has a current calculated panel reactive antibody (cPRA) level >50%