NCT00527215已完成2 期
A Study of Darbepoetin Alfa Administered Once Every Four Weeks in Chronic Renal Insufficiency (CRI) Subjects With Anemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 98
- 主要终点
- To assess the proportion of CRI subjects maintaining a target hemoglobin (Hb) range of 10.0 to 12.0 g/dL when administered subcutaneous (SC) darbepoetin alfa once every 4 weeks
研究概览
简要总结
Multicenter, open label single arm study in which 140 subjects with CRI who are currently receiving SC darbepoetin alfa once every other week will receive darbepoetin alfa once every 4 weeks for 24 weeks. Upon enrollment into this study, subjects will receive darbepoetin alfa once every 4 weeks for 24 weeks. The initial dose will be equivalent to the subject's total dose in the month preceding enrollment. Doses may be titrated to maintain the Hb concentration in the target range.
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
- •Greater than or equal to 18 years of age
- •CRI with a creatinine clearance of greater than 15 but less than 40 mL/min
- •Stable once every other week darbepoetin alfa SC for at least 6 weeks
- •Hb values during screening / baseline of 10.0 - 12.0 g/dL
- •Serum B12 and folate levels above the lower limit of normal and iron replete
排除标准
- •Receiving renal replacement therapy
- •Uncontrolled hypertension
- •Hyperparathyroidism
- •Major surgery, active inflammatory disease, receiving antibiotics, HIV-positive
- •Current malignancy
- •Pregnant or breast-feeding
研究组 & 干预措施
darbepoetin alfa
Experimental
干预措施: darbepoetin alfa (Drug)
结局指标
主要结局
To assess the proportion of CRI subjects maintaining a target hemoglobin (Hb) range of 10.0 to 12.0 g/dL when administered subcutaneous (SC) darbepoetin alfa once every 4 weeks
时间窗: Study weeks 21 - 29
次要结局
- To assess the safety, toleratbility, and pharmacokinetic (PK) profile of darbepoetin alfa when administered once every 4 weeks.(Entire study)
研究者
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