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

Astellas Pharma Global Development, Inc.42 个研究点分布在 1 个国家目标入组 149 人开始时间: 2013年3月5日最近更新: 2025年11月21日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Astellas Pharma Global Development, Inc.
入组人数: 149
试验地点: 42
主要终点: Biopsy-proven acute (T or B cell) rejection (BPAR) (Banff 2007 Grade ≥ 1) by local review

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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).

详细描述

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).

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Subject is a recipient of a de novo kidney from a living or deceased donor

排除标准

•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%

研究组 & 干预措施

Standard of Care

Active Comparator

Basiliximab induction + Tacrolimus + MMF + Corticosteroids

干预措施: Tacrolimus (Drug)

Standard of Care

Active Comparator

Basiliximab induction + Tacrolimus + MMF + Corticosteroids

干预措施: Mycophenolate Mofetil (MMF) (Drug)

Standard of Care

Active Comparator

Basiliximab induction + Tacrolimus + MMF + Corticosteroids

干预措施: Basiliximab (Drug)

Standard of Care

Active Comparator

Basiliximab induction + Tacrolimus + MMF + Corticosteroids

干预措施: Methylprednisone (Drug)

Standard of Care

Active Comparator

Basiliximab induction + Tacrolimus + MMF + Corticosteroids

干预措施: Prednisone (Drug)