EUCTR2014-000712-34-SE进行中（未招募）1 期
A PHASE II STUDY TO EVALUATE THE SAFETY, TOLERABILITY, EFFICACY AND PHARMACOKINETICS OF INTRAVENOUS ASCENDING DOSES OF IDES IN KIDNEY TRANSPLANTATIO
Hansa Medical AB0 个研究点开始时间: 2014年6月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •1.Age 18 years or above
- •2.Patients diagnosed with CKD and in dialysis with one of the following conditions will be included:
- •Preformed anti-HLA antibodies (non-DSA, DSA or both), negative T-CDC CXM and at least one antibody MFI > 3000
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 12
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •Clinical signs of ongoing infectious disease. This includes P-CRP >10.
- •Severe other conditions requiring treatment and close monitoring, e.g. cardiac failure > NYHA (New York Heart Association) grade 3, unstable coronary disease or oxygen dependent COPD
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