NCT00359840已完成2 期
A Randomized, Dose - Finding Study of KRN321(Darbepoetin Alfa) for the Treatment of Anemia in Subjects With Solid Tumor
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 8
- 主要终点
- To compare the effectiveness of KRN321(darbepoetin alfa) on the proportion of subjects achieving hemoglobin response
研究概览
简要总结
To assess the clinical effective dose of KRN321 administered with once triweekly schedule.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients diagnosed as solid tumor or malignant lymphoma
- •patients receiving cyclic chemotherapy
- •written informed consent
- •hemoglobin concentration below 11 d/dL at enrollment
- •life expectancy of more than 4 months
排除标准
- •hemolysis, gastrointestinal bleeding, postoperative bleeding
- •iron deficiency
- •megaloblastic anemia
- •received > 2 RBC transfusions within 4 weeks before randomization or any RBC transfusion within 2 weeks before randomization
- •any primary hematological disorder that could cause anemia
- •prior treatment with KRN321
- •received erythropoetin therapy within 8 weeks before treatment
结局指标
主要结局
To compare the effectiveness of KRN321(darbepoetin alfa) on the proportion of subjects achieving hemoglobin response
次要结局
- To compare the proportion of subjects who receive red blood cell transfusions or show the hemoglobin level below 8 g/dL
- To compare the proportion of subjects who receive red blood cell transfusions
- To compare the effectiveness of KRN321 based on quality of life scores
研究者
研究点 (8)
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