ate Phase 2 Double-Blind Study to Assess the Dose-Response of JTZ-951 in Anemic Patients with Chronic Kidney Disease Receiving Maintenance Hemodialysis <Anemia Correction / Maintenance Study>

Japan Tobacco Inc.0 个研究点目标入组 71 人开始时间: 2015年5月11日最近更新: 2023年10月17日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Japan Tobacco Inc.
入组人数: 71

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

JTZ-951 had a dose-response relationship with Hb level increase rate. 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 = > 8.5 g/dL and < 10.0 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

发起方

Japan Tobacco Inc.

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