Overview

This trial is active, not recruiting.

Condition kidney transplantation
Treatments askp1240, tacrolimus, mycophenolate mofetil (mmf), basiliximab, methylprednisone, prednisone
Phase phase 2
Sponsor Astellas Pharma Global Development, Inc.
Collaborator Kyowa Hakko Kirin Company, Limited
Start date February 2013
End date June 2014
Trial size 149 participants
Trial identifier NCT01780844, 7163-CL-0108

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Basiliximab induction + Tacrolimus + MMF + Corticosteroids
tacrolimus Prograf®
intravenous or oral
mycophenolate mofetil (mmf) CellCept®
intravenous or oral
basiliximab Simulect®
intravenous
methylprednisone
Intravenous
prednisone
Oral
(Experimental)
Basiliximab induction + ASKP1240 + MMF + Corticosteroids
askp1240
intravenous infusion
mycophenolate mofetil (mmf) CellCept®
intravenous or oral
basiliximab Simulect®
intravenous
methylprednisone
Intravenous
prednisone
Oral
(Experimental)
Basiliximab induction + ASKP1240 + Tacrolimus + Corticosteroids
askp1240
intravenous infusion
tacrolimus Prograf®
intravenous or oral
basiliximab Simulect®
intravenous
methylprednisone
Intravenous
prednisone
Oral

Primary Outcomes

Measure
Biopsy-proven acute (T or B cell) rejection (BPAR) (Banff 2007 Grade ≥ 1) by local review
time frame: 6 months

Secondary Outcomes

Measure
Glomerular Filtration Rate (GFR)
time frame: 6 months
Patient Survival
time frame: 6 months
Graft Survival
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

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%

Additional Information

Official title 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
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).
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Astellas Pharma Inc.