A Study to Assess the Efficacy and Safety of ASKP1240 in de Novo Kidney Transplant Recipients

Astellas

Status and phase: Completed; Phase 2

Conditions: Kidney Transplantation

Treatments: Drug: ASKP1240; Drug: Tacrolimus; Drug: Methylprednisone; Drug: Prednisone; Drug: Basiliximab; Drug: Mycophenolate Mofetil (MMF)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01780844

7163-CL-0108

Details and patient eligibility

About

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).

Full description

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).

Enrollment: 149 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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149 participants in 3 patient groups

Standard of Care

Active Comparator group

Description:

Basiliximab induction + Tacrolimus + MMF + Corticosteroids

Treatment:

Drug: Methylprednisone

Drug: Prednisone

Drug: Mycophenolate Mofetil (MMF)

Drug: Basiliximab

Drug: Tacrolimus

CNI avoidance

Experimental group

Description:

Basiliximab induction + ASKP1240 + MMF + Corticosteroids

Treatment:

Drug: Methylprednisone

Drug: Prednisone

Drug: Mycophenolate Mofetil (MMF)

Drug: Basiliximab

Drug: ASKP1240

CNI minimization-MMF avoidance

Experimental group

Description:

Basiliximab induction + ASKP1240 + Tacrolimus + Corticosteroids

Treatment:

Drug: Methylprednisone

Drug: Prednisone

Drug: Basiliximab

Drug: Tacrolimus

Drug: ASKP1240