EUCTR2007-005728-34-GB进行中（未招募）1 期
Post authorisation 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. - not applicable
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Hexal AG
- 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
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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