EUCTR2007-005728-34-IT进行中（未招募）不适用
Post-authorization safety study to prospectively monitor the incidence of relevant drug-related adverse events and EPO-related lack of efficacy among CKD subjects receiving HX575 recombinant human erythropoietin alfa i.v. - ND
HEXAL BIOTECH0 个研究点目标入组 1,500 人开始时间: 2008年10月21日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,500
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
- •CKD subjects with or without dialysis treatment Age > or ═ 18 years Subjects requiring i.v. ESA treatment Subjects likely to remain on i.v. ESA treatment equal or more than 6 months Provision of informed consent
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Systemic immunosuppressive medication or any other drugs known to adversely affect the hemoglobin level Known primary lack of efficacy (LOE), unexplained loss of effect to a recombinant erythropoietin product History of PRCA or aplasic anemia History of anti-erythropoietin antibodies Uncontrolled hypertension Pregnant woman or nursing mother Women of childbearing potential do not agree to maintain effective birth control during the study treatment period.
研究者
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