NCT02936479已完成2 期
Use of C1-INH (Berinert) for Renal Allograft Salvage in Refractory Antibody Mediated Rejection
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Renal Allograft Survival Measured by Severe and Refractory Antibody Mediated Renal (AMR)
研究概览
简要总结
This is an open-label, single arm trial in which patient who have ongoing antibody mediated rejection of a kidney transplant deemed refractory to maximal medical therapy are given the complement inhibitor C1-INH (Berinert) in an effort to protect the graft from ongoing antibody mediated injury. A maximum of 5 patients will be enrolled.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Kidney transplant with acute antibody mediated rejection refractory to standard therapy
排除标准
- •Patients with known intolerance of or anaphylaxis to Berinert
研究组 & 干预措施
Berinert treatment
Experimental
干预措施: C1-INH (Berinert) (Drug)
结局指标
主要结局
Renal Allograft Survival Measured by Severe and Refractory Antibody Mediated Renal (AMR)
时间窗: 24 months
number of patients that presented with severe and refractory Antibody Mediated Renal (AMR) following kidney transplant and survived beyond one year after study drug administration
次要结局
未报告次要终点
研究者
研究点 (1)
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