NCT01997892已完成不适用
TRANSFORM - Observational Cohort Study of Aranesp Use in EU Haemodialysis Patients Switched From Mircera
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 1,027
- 试验地点
- 1
- 主要终点
- Hemoglobin Concentration at Monthly Intervals
研究概览
简要总结
To describe the time course of hemoglobin concentration in EU hemodialysis patients switched from methoxy polyethylene glycol-epoetin beta (PEG epoetin beta; Mircera) to darbepoetin alfa (Aranesp).
详细描述
This is a multi-centre, observational cohort study of EU hemodialysis patients whose erythropoiesis stimulating agent (ESA) therapy has been switched from PEG epoetin beta to darbepoetin alfa. Data will be collected for the period spanning 14 weeks prior to switch through to 26 weeks post-switch.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
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
- •Patients >18 years of age. CKD diagnosis, receiving hemodialysis
- •Received PEG epoetin beta for 14weeks prior to switching to darbepoetin alfa and received at least one dose of darbepoetin alfa.
排除标准
- 未提供
结局指标
主要结局
Hemoglobin Concentration at Monthly Intervals
时间窗: Month -3, -2, -1 (pre-switch), and Month 1, 2, 3, 4, 5 and 6 (post-switch)
Hemoglobin concentration from 3 months prior to switch to darbepoetin alfa until the end of the observation period.
次要结局
- PEG Epoetin Beta Dose From the Start of the Observation Period Until the Switch(Month -3, Month -2, Month -1)
- Darbepoetin Alfa Dose From the Switch Date Until the End of the Observation Period(Month 1, 2, 3, 4, 5 and 6)
- Dose Ratio Measured at the Time of Switch From PEG Epoetin Beta to Darbepoetin Alfa(Week -1 and Week 1)
- Hemoglobin Concentration Rate of Change by Period(Thre months prior to switch and 6 months after the switch)
- Percentage of Participants With Hemoglobin Excursions(Month -3, -2, -1, 1, 2, 3, 4, 5 and 6)
研究者
研究点 (1)
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