An Open-Label, Single-Arm, Multicenter Trial to Determine Safety and Efficacy of Eculizumab in the Prevention of Antibody Mediated Rejection (AMR) in Sensitized Recipients of a Kidney Transplant From a Deceased Donor.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 主要终点
- Post-transplantation Treatment Failure In The First 9 Weeks Post Transplantation
研究概览
简要总结
Primary Objective:
To evaluate the safety and potential efficacy of eculizumab to prevent AMR in sensitized recipients of deceased donor kidney transplants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Male or female participants ≥18 years old.
- •Participants with Stage V chronic kidney disease who received a kidney transplant from a deceased donor to whom they were sensitized.
- •History of prior exposure to HLA (human leukocyte antigen):
- •Prior solid organ or tissue allograft
- •Pregnancy
- •Blood transfusion
- •Prior exposure to specific donor's HLA
排除标准
- •Has received treatment with eculizumab at any time prior to enrolling in this study.
- •Blood type (A, B, and O blood glycoproteins-blood type) incompatible with deceased donor.
- •History of severe cardiac disease.
- •Prior splenectomy.
研究组 & 干预措施
Eculizumab
Eculizumab 1200 milligrams (mg) was administered intravenously (IV) over 25 to 45 minutes 1 hour prior to kidney allograft reperfusion.
Eculizumab 900 mg was administered IV over 25 to 45 minutes on post-transplantation Days 1 and 7, and on post-transplantation Days 14, 21, and 28, plus or minus 2 days.
Eculizumab 1200 mg was administered IV over 25 to 45 minutes on post-transplantation Days 35, 49, and 63, plus or minus 2 days.
干预措施: Eculizumab (Drug)
结局指标
主要结局
Post-transplantation Treatment Failure In The First 9 Weeks Post Transplantation
时间窗: Baseline, Week 9
Results are reported for post-transplantation treatment failure and composite endpoints, defined as the occurrence of biopsy-proven acute antibody-mediated rejection (AMR), graft loss, death, or loss to follow-up (including discontinuation) in the first 9 weeks post transplantation. The diagnosis of acute AMR (occurring within the first 9 weeks post transplantation) was based on kidney allograft dysfunction and a biopsy performed due to suspected rejection, proteinuria, increased serum creatinine, or acute tubular necrosis. Treatment failure was the occurrence of at least 1 of the composite endpoint components by Week 9 post transplantation. A participant experiencing multiple events was only counted once for the composite endpoint.
次要结局
未报告次要终点