NCT02392312已完成不适用
Safety and Efficacy of Individual Batches of ATG-F in Kidney Transplant Recipients: Multicentre, Prospective, Observational Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 950
- 试验地点
- 25
- 主要终点
- Incidence and severity of adverse event
研究概览
简要总结
A multicenter, prospective, observational study to evaluate the safety and efficacy of individual batches of ATG-F in kidney transplant recipients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •ATG-F administration to prophylaxis rejection in kidney transplantation recipient.
- •Patients capable to understand the purposes and risks of the study, who are willing and able to participate in the study and from whom written and dated informed consent to participate in the study is obtained.
排除标准
- •Hypersensitivity to the active substance or to any of the excipients.).
- •Subjects with bacterial, viral, mycotic or parasitic infections, which are not under adequate therapeutic control.
- •Solid organ transplant subjects with severe thrombocytopenia, i.e. less than 50,000 platelets/µl because ATG-F may enhance thrombocytopenia and thus increase the risk of hemorrhage.
- •Current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix that has been treated successfully.
- •Subject is receiving a Human Leukocyte Antibody (HLA) identical living donor organ.
- •Subject is unlikely to comply with the visits scheduled in the protocol in the opinion of investigator or has a history of non-compliance.
研究组 & 干预措施
ATF-Fresenius S
intravenous
干预措施: ATF-Fresenius S (Drug)
结局指标
主要结局
Incidence and severity of adverse event
时间窗: up to 3 months post-transplantation
次要结局
- Clinical diagnosis of acute rejection(up to 3 months post-transplantation)
- Renal function: serum creatinine(at month 1 and month 3)
- Incidence of delayed graft function (DGF)(up to 3 months post-transplantation)
- Patient and graft survival(up to 3 months post-transplantation)
研究者
研究点 (25)
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