EUCTR2012-000441-12-DE进行中（未招募）1 期
A randomized, double-blind, placebo-controlled pilot study to evaluate the safety and effect of Cinryze (C1 Esterase Inhibitor (Human)) for the treatment of acute antibody-mediated rejection in recipients of donor-sensitized kidney transplants.
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- age : 18 years or older
- •- weight : above or equal to 50 kg
- •- Identified Human Leukocyte Antigen (HLA) donor-specific antibody (DSA)
- •- Achievement of adequate function of kidney transplant, as determined by creatinine clearance above or equal to 40 ml/min, within the first 4 weeks post-transplant
- •- First qualifying AMR episode, within 12 months after transplant
- •- Able to receive first dose of study drug, within 72 hours after the qualifying renal allograft biopsy that was diagnostic for AMR
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 19
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •- have received a deceased donor kidney with any of the following characteristics (Banff classification >=2 for arteriosclerosis, interstitial fibrosis or tubular atrophy ; pediatric and bloc kidney transplant)
- •- Rapid onset of severe oliguric AMR
- •- Any surgical or medical condition that could interfere with the administration of study drug or interpretation of study results
- •- Any infection that causes hemodynamic compromise
- •- History of abnormal bleeding, clotting or any coagulopathy
- •- History of allergic reaction to C1 esterase inhibitor or other blood products
- •- Participation in the active dosing phase of any other investigational drug study within 30 days prior to dosing with the study drug
- •- Pregnancy or breastfeeding
- •- Within 48 hours prior to dosing with study drug, white blood cell count < 0.5*10e9/l or > 20*10e9/l
- •- Within 48 hours prior to dosing with study drug, platelet count < 25*10e9/l or > 600*10e9/l
- •- Receipt of any of the following AMR agents, within one month prior to the first dose of study drug : Eculizumab, Ecallantide, Bortezomib, any C1 esterase inhibitor
研究者
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