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临床试验/JPRN-jRCT2080222207
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>

Japan Tobacco Inc.0 个研究点目标入组 40 人开始时间: 2013年9月3日最近更新:
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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