A Phase III Trial to Compare the Safety and Efficacy of Intravenous UB-851 and Eprex® With an Extension Safety Evaluation in Subjects With Renal Anemia on Hemodialysis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 269
- 主要终点
- Adverse events (AEs): incidence and severity of all drug-related AEs
研究概览
简要总结
The primary objective of this study is to evaluate a 1:1 dose conversion from Eprex® to UB-851 in terms of clinical efficacy and safety in subjects with chronic renal failure receiving hemodialysis.
详细描述
This is a 52-week, phase III trial consisting of two parts:
Part I is designed as a double-blind, randomized, multicenter, parallel-group study to evaluate the efficacy and safety of UB-851 in comparison to Eprex® in subjects with renal anemia on hemodialysis with a treatment period of 24 weeks.
Part II is designed as a single-arm, safety evaluation period (from week 25 to week 52) to evaluate the long-term safety and immunogenicity of UB-851.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main Inclusion Criteria:
- •Subjects signed informed consent before undergoing any study procedures.
- •Subjects aged 20 to 85 years.
- •Hemodialysis subjects with chronic renal failure and renal anemia in outpatient clinic currently on stable Eprex® treatment administered by intravenous injection (1 to 3 times per week) for at least 3 months prior to randomization.
排除标准
- •Maintenance epoetin dose > 300 IU/kg per week.
- •Treatment with long-acting epoetin analogues.
- •Detectable anti-erythropoietin antibodies with clinical symptoms at screening visit, or history of Pure Red Cell Aplasia (PRCA).
研究组 & 干预措施
Eprex then UB-851
干预措施: UB-851 (Biological)
Eprex then UB-851
干预措施: Eprex (Biological)
UB-851
干预措施: UB-851 (Biological)
结局指标
主要结局
Adverse events (AEs): incidence and severity of all drug-related AEs
时间窗: up to 52 weeks
Mean change in hemoglobin (Hb) levels
时间窗: Baseline and the evaluation period (evaluation period: Week21-Week24)
Mean change in weekly epoetin dosage. between baseline and the evaluation period
时间窗: Baseline and the evaluation period (evaluation period: Week21-Week24)
Immunogenicity: occurrence of anti-erythropoietin antibody
时间窗: up to 52 weeks
次要结局
未报告次要终点