A Study to Assess the Efficacy and Safety of ASKP1240 in de Novo Kidney Transplant Recipients
Status: | Completed |
---|---|
Conditions: | Renal Impairment / Chronic Kidney Disease |
Therapuetic Areas: | Nephrology / Urology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/22/2017 |
Start Date: | March 5, 2013 |
End Date: | January 27, 2017 |
A Phase 2a, Randomized, Open-label, Active Control, Multi-Center Study to Assess the Efficacy and Safety of ASKP1240 in de Novo Kidney Transplant Recipients
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).
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).
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%
We found this trial at
36
sites
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