NCT00436995已完成3 期
A Multicentre, Single Arm Study Evaluating The Extension From Weekly To Once Every Other Week Darbepoetin Alfa Administration In Subjects With Chronic Kidney Disease Receiving Dialysis.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 114
- 主要终点
- Haemoglobin values to be maintained at greater than 11.0 g/dL during the evaluation period.
研究概览
简要总结
The purpose of this study is to assess the proportion of subjects sucessfully achieving a mean Hemoglobin greater than or equal to 11 g/dL during the evaluation period following extension from Weekly (QW) to Once Every Other Week (Q2W) Darbepoetin Alfa administraion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Receiving dialysis for 3 months or more before enrollment.
- •The mean of 2 screening Hb values taken at least 7 days appart must be greater than or equal to 11g/dL and less than or equal to 13.0 g/dL
- •Receiving stable QW darbepoetin alfa doses for at least 6 weeks before enrollment
- •Adequate iron stores (serum ferritin equal to or greater than 100 ug/L
排除标准
- •Uncontrolled hypertension
- •Prior history of Cardiovascular Incidents 12 weeks prior to enrollment
- •Other hematological disorders
- •Upper or lower GI bleed within the prior 6 months
研究组 & 干预措施
Single
Other
干预措施: Darbepoetin Alfa (Drug)
结局指标
主要结局
Haemoglobin values to be maintained at greater than 11.0 g/dL during the evaluation period.
时间窗: 33 weeks
次要结局
- Q2W doses over duration of study.(33 weeks)
- Hb values during the evaluation period.(33 weeks)
- adverse events during study(33 weeks)
- Hb Rate of Rise during study and excursions above 14g/dL(33 weeks)
研究者
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