NCT02912494已完成3 期
A Phase III Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 主要终点
- Change from baseline in Hemoglobin level
研究概览
简要总结
The purpose of this study is to investigate the equivalence of JR-131 to Darbepoetin alfa and evaluate the safety of JR-131 in renal anemia patients with chronic kidney disease (CKD).
研究设计
- 研究类型
- Interventional
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients being treated with Darbepoetin alfa.
排除标准
- •Patients having complication or history of a cardiovascular / lung / brain infarction.
- •Patients having a pronounced hemorrhagic lesion.
研究组 & 干预措施
JR-131
Experimental
干预措施: JR-131 (Drug)
Darbepoetin alfa
Active Comparator
干预措施: Darbepoetin alfa (Drug)
结局指标
主要结局
Change from baseline in Hemoglobin level
时间窗: 24 weeks
次要结局
未报告次要终点
研究者
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