JPRN-jRCT2080222829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 Not Requiring Dialysis <Anemia Correction / Switch / Maintenance Study>
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 201
研究概览
简要总结
JTZ-951 had a dose-response relationship with Hb increase rate. The proportion of subjects who maintained an Hb within the range of the baseline +-1.0 g/dL at endpoint tended to be higher in the JTZ-951 2 and 4 mg arms than in the placebo arm, although there were no significant differences. The Hb at EOT was increased with dose. Hb was maintained within the range of 10 to 12 g/dL when administered at doses adjusted based on Hb. JTZ-951 is confirmed to be safe when administered for 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 with chronic kidney disease not requiring dialysis
- •* Group 1 (ESA-naive): Hemoglobin level of = > 8.0 and = < 10.5 g/dL
- •* Group 2 (ESA-treated): Hemoglobin level of = > 9.5 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 mepitiostane within 12 weeks preceding the study
- •* Severe infection, Systemic hematological disease, hemolytic anemia or hemorrhagic lesion
研究者
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