JPRN-jRCT2080222207已完成2 期
An Early Phase 2 Study to Explore the Efficacy and Safety of JTZ-951 in Renal Anemic Patients Receiving Maintenance Hemodialysis <Anemia Correction study>
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
研究概览
简要总结
The efficacy and safety of JTZ-951 were demonstrated in anemic patients with CKD receiving maintenance hemodialysis.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 74age old(—)
- 性别
- All
入选标准
- •Patients receiving hemodialysis consistently 3 times weekly
- •-Pre-dialysis hemoglobin level of= > 9.0 g/dL and < 10.0 g/d
排除标准
- •-Uncontrollable hypertension
- •-Congestive heart failure (NYHA classification III or higher)
- •-Excessive bleeding associated with surgical operation or blood transfusion within 12 weeks preceding the study
- •-IV iron replacement therapy within 4 weeks preceding the study
- •-Using anabolic androgenic steroid, testosterone enanthate or mepitiostan within 12 weeks preceding the study
- •-Severe infection, Systemic hematological disease, hemolytic anemia or hemorrhagic lesion
研究者
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