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).

Subjects will be followed for 6 months. Upon completion of the first 6 months of the study, subjects may participate in the Long Term Extension period of the study. Subjects will remain on their original treatment arm up to three years post-transplant (and / or Sponsor discontinues development or the subject no longer wishes to participate in the study).

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%

Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency.