A Study to Assess the Efficacy and Safety of ASKP1240 in de Novo Kidney Transplant Recipients
- Conditions
- Kidney Transplantation
- Interventions
- Registration Number
- NCT01780844
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Brief 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).
- Detailed 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 149
- Subject is a recipient of a de novo kidney from a living or deceased donor
- 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%
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard of Care Mycophenolate Mofetil (MMF) Basiliximab induction + Tacrolimus + MMF + Corticosteroids CNI avoidance ASKP1240 Basiliximab induction + ASKP1240 + MMF + Corticosteroids CNI avoidance Mycophenolate Mofetil (MMF) Basiliximab induction + ASKP1240 + MMF + Corticosteroids CNI minimization-MMF avoidance ASKP1240 Basiliximab induction + ASKP1240 + Tacrolimus + Corticosteroids Standard of Care Tacrolimus Basiliximab induction + Tacrolimus + MMF + Corticosteroids Standard of Care Basiliximab Basiliximab induction + Tacrolimus + MMF + Corticosteroids Standard of Care Prednisone Basiliximab induction + Tacrolimus + MMF + Corticosteroids Standard of Care Methylprednisone Basiliximab induction + Tacrolimus + MMF + Corticosteroids CNI avoidance Methylprednisone Basiliximab induction + ASKP1240 + MMF + Corticosteroids CNI avoidance Basiliximab Basiliximab induction + ASKP1240 + MMF + Corticosteroids CNI avoidance Prednisone Basiliximab induction + ASKP1240 + MMF + Corticosteroids CNI minimization-MMF avoidance Tacrolimus Basiliximab induction + ASKP1240 + Tacrolimus + Corticosteroids CNI minimization-MMF avoidance Basiliximab Basiliximab induction + ASKP1240 + Tacrolimus + Corticosteroids CNI minimization-MMF avoidance Methylprednisone Basiliximab induction + ASKP1240 + Tacrolimus + Corticosteroids CNI minimization-MMF avoidance Prednisone Basiliximab induction + ASKP1240 + Tacrolimus + Corticosteroids
- Primary Outcome Measures
Name Time Method Biopsy-proven acute (T or B cell) rejection (BPAR) (Banff 2007 Grade ≥ 1) by local review 6 months
- Secondary Outcome Measures
Name Time Method Glomerular Filtration Rate (GFR) 6 months GFR is based on Modification of Diet in Renal Disease (4 variable-MDRD) criteria
Patient Survival 6 months Subject survival is defined as any subject who does not die during the study.
Graft Survival 6 months Graft survival is defined as any subject who does not experience graft loss during the study. Graft loss is defined as subject death, retransplantation, transplant nephrectomy, or the permanent return to dialysis (greater than 30 days).
Trial Locations
- Locations (42)
Site US10038
🇺🇸Pittsburgh, Pennsylvania, United States
Site US10007
🇺🇸Atlanta, Georgia, United States
Site US10018
🇺🇸Chicago, Illinois, United States
Site US10029
🇺🇸Houston, Texas, United States
Site US10044
🇺🇸Houston, Texas, United States
Site US10021
🇺🇸Palo Alto, California, United States
Site US10032
🇺🇸Cleveland, Ohio, United States
Site US10027
🇺🇸Harrisburg, Pennsylvania, United States
Site US10026
🇺🇸Greenville, North Carolina, United States
Site US10001
🇺🇸Dallas, Texas, United States
Site US10006
🇺🇸Birmingham, Alabama, United States
Site US10004
🇺🇸San Francisco, California, United States
Site US10003
🇺🇸San Francisco, California, United States
Site US10013
🇺🇸Aurora, Colorado, United States
Site US10033
🇺🇸Salt Lake City, Utah, United States
Site US10030
🇺🇸San Diego, California, United States
Site US10041
🇺🇸Augusta, Georgia, United States
Site US10037
🇺🇸Chicago, Illinois, United States
Site US10010
🇺🇸Chicago, Illinois, United States
Site US10014
🇺🇸Baltimore, Maryland, United States
Site US10042
🇺🇸Charlotte, North Carolina, United States
Site US10025
🇺🇸Saint Louis, Missouri, United States
Site US10019
🇺🇸Bronx, New York, United States
Site US10022
🇺🇸Livingston, New Jersey, United States
Site US10031
🇺🇸Buffalo, New York, United States
Site US10023
🇺🇸New York, New York, United States
Site US10034
🇺🇸New York, New York, United States
Site US10016
🇺🇸Durham, North Carolina, United States
Site US10040
🇺🇸Cleveland, Ohio, United States
Site US10035
🇺🇸Nashville, Tennessee, United States
Site US10028
🇺🇸Memphis, Tennessee, United States
Site US10002
🇺🇸Fort Worth, Texas, United States
Site US10020
🇺🇸Charlottesville, Virginia, United States
Site US10024
🇺🇸Phoenix, Arizona, United States
Site US10009
🇺🇸Cincinnati, Ohio, United States
Site US10005
🇺🇸Madison, Wisconsin, United States
Site US10008
🇺🇸Los Angeles, California, United States
Site US10045
🇺🇸New Orleans, Louisiana, United States
Site US10017
🇺🇸Ann Arbor, Michigan, United States
Site US10036
🇺🇸Chapel Hill, North Carolina, United States
Site US10012
🇺🇸Charleston, South Carolina, United States
Site US10015
🇺🇸Lexington, Kentucky, United States