Observational Study of Correction of Anaemia With Darbepoetin Alfa at Monthly Dose Frequency in EU and Australian Patients With Chronic Kidney Disease Not on Dialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 308
- 试验地点
- 1
- 主要终点
- Monthly Haemoglobin values
研究概览
简要总结
To describe anaemia correction via haemoglobin measurements taken throughout observation period in ESA naive patients with chronic kidney disease initiated on darbepoetin alfa QM
详细描述
Darbepoetin alfa (Aranesp) is a long-acting ESA approved for treatment of anaemia in CKD patients, and may be administered once a week (QW), once every two weeks (Q2W) or once a month (QM) for correction and for maintenance in CKD patients not on dialysis. Prescribing information for darbepoetin alfa was updated in August 2013 (in EU and Australia), to incorporate the option for correction at QM dosing frequency in CKD patients not on dialysis. There is very little published literature describing QM correction in a real-world setting.
Data obtained from this study are intended to contribute to filling a literature gap and to provide a robust source of information for physicians.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥18 years of age.
- •Patients with CKD:
- •Not on dialysis at time of darbepoetin alfa initiation at QM dosing frequency.
- •Hb <10g/dL immediately prior to initiation of darbepoetin alfa at QM dosing.
- •Commenced darbepoetin alfa at QM dosing frequency during or after August
- •Received at least three consecutive doses of darbepoetin alfa at QM dosing frequency, being the initiation dose and two further doses at QM dosing frequency.
- •Patient or patient's legally acceptable representative has provided informed consent, if applicable according to local requirements.
排除标准
- •Treatment with an ESA within 14 weeks prior to initiation of darbepoetin alfa.
- •Patient was enrolled in an interventional device or drug study at any time during the 46-week data observation period or within 30 days prior to commencement of the data observtion period.
结局指标
主要结局
Monthly Haemoglobin values
时间窗: During the 32 weeks post initiation of darbepoetin alfa QM
Monthly Hb within 10-12g/dL during the 32 weeks post initiation of darbepoetin alfa QM
次要结局
- Haemoglobin values(Throughout the 46 week observation period)
- Change in Haemoglobin values(Throughout the 46 week observation period)
- TSAT, ferritin and albumin values(Throughout the 46 week observation period)
- Subjects remaining on darbepoetin alfa QM(During the 32 weeks post initiation of darbepoetin alfa QM)
- Doses of darbepoetin alfa/other ESAs over time(Throughout the 46 week observation period)
- first dose frequency change after third dose of darbepoetin alfa QM(During the 32 weeks post initiation of darbepoetin alfa QM)
- Hospitalisations(Throughout the 46 week observation period)
- Increase in haemoglobin from baseline(Throughout the 46 week observation period)
- Haemoglobin excursions(Throughout the 46 week observation period)
- First haemoglobin within 10-12g/dL(During the 32 weeks post initiation of darbepoetin alfa QM)
- Iron Use(Throughout the 46 week observation period)
- Transfusions(Throughout the 46 week observation period)