Retrospective Study of Stable Haemodialysis Patients Switched From Darbepoetin Alfa to Epoetin Alfa Biosimilar
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 272
- 试验地点
- 1
- 主要终点
- Haemoglobin Concentration
研究概览
简要总结
The study will obtain data to show insight into clinical outcomes of patients switching from Darbepoetin Alfa to a epoetin alfa biosimilar.
详细描述
Biosimilars were approved in 2007 by the EMA in EU and in 2010 by the TGA in Australia. This study will look at the retrospective data of patients that have switched from Darbepoetin Alfa to an approved epoetin alfa biosimilar. Data will be collected for the 26 week period prior to switch and a 26 week period post switch to a biosimilar. Data to be collected includes haemoglobin measurements, dose requirements, iron use, any transfusions, hospitalisations and other lab values including TSAT, Ferritin and albumin. Data from the study will be published.
研究设计
- 研究类型
- Observational
- 时间视角
- Retrospective
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
- 未提供
排除标准
- •Treatment with an ESA other than darbepoetin alfa during the 12 weeks prior to switch to biosimilar
- •More than 14 days' cumulative treatment with short-acting ESA during weeks 26-13 prior to switch to biosimilar
- •Subject received chemotherapy or major surgery during the 26 weeks prior to switch to biosimilar
- •Subject was enrolled in an interventional device or drug study at any time during the 52-week data observation period or within 30 days prior to commencement of the data observation period.
结局指标
主要结局
Haemoglobin Concentration
时间窗: Duration of observation period -52 weeks
Mean haemoglobin concentration over time
次要结局
- ESA Doses(Duration of observation period -52 weeks)
- Dose ratio(Between end of post-switch (weeks 23-26) and pre-switch (weeks -4--1))
- Haemoglobin excursions(Duration of observation period -52 weeks)
- TSAT, ferritin and albumin values(Duration of observation period -52 weeks)
- Haemglobin within range(Duration of observation period -52 weeks)
- Iron Use(Duration of observation period -52 weeks)
- Hospitalisations (including primary cause)(Duration of observation period -52 weeks)
- Red cell transfusions (including number of units transfused)(Duration of observation period -52 weeks)