JPRN-jRCT2080223814已完成3 期
Phase 3 Study to Compare the Efficacy and Safety of JTZ-951 with Darbepoetin Alfa in Anemic Patients with Chronic Kidney Disease Not Requiring Dialysis <Anemia Correction / Switch / Maintenance Study> (SYMPHONY ND)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 216
研究概览
简要总结
SYMPHONY ND demonstrated that JTZ-951 was as effective as DA in maintaining Hb levels in anemic patients with CKD not requiring dialysis, and was generally well-tolerated over 24 weeks.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •ESA naive patients:
- •Hemoglobin level of => 8.0 g/dL and =< 10.5 g/dL
- •ESA treated patients:
- •Hemoglobin level of => 9.5 g/dL and =< 12.0 g/d
排除标准
- •Patients with poorly controlled hypertension
- •Patients with congestive heart failure or unstable angina
- •Patients with malignancy
研究者
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