JPRN-jRCT2080222840已完成2 期
ate Phase 2 Double-Blind Study to Assess the Dose-Response of JTZ-951 in Anemic Patients with Chronic Kidney Disease Receiving Maintenance Hemodialysis <Switch / Maintenance Study>
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 85
研究概览
简要总结
The proportion of subjects who maintained an Hb level within the range of the baseline value +-1.0 g/dL at endpoint tended to be higher in the JTZ-951 arms than in the placebo arm, although there were no significant differences. The Hb level at EOT was increased with JTZ-951 dose. Hb level was maintained within the range of 10 to 12 g/dL when JTZ-951 was administered at doses adjusted based on Hb levels. JTZ-951 is confirmed to be safe when administered for a total of up to 30 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
- •*Patients receiving hemodialysis consistently 3 times weekly
- •*Hemoglobin level of = > 9.5 g/dL and = < 12.0 g/d
排除标准
- •*Uncontrollable hypertension
- •*Congestive heart failure (NYHA classification III or higher)
- •*Blood transfusion or excessive bleeding associated with surgical operation 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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