NCT01807481Unknown4 期
A Prospective,Single-arm,Multicenter Study to Evaluate the Efficacy and Safety of Mircera in Peritoneal Patients Who Already Had Been Treated With ESA
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Number of patients with hemoglobin 10~12 g/dl
研究概览
简要总结
The primary objective of study is to evaluate the no of patients which maintain the Hb level between 9.0 ~ 12.0 g/dl during the evaluation period
详细描述
The secondary objective of study is
- No of patients with mean Hb level of +/-1.0g/dl difference from the baseline Hb
- Incidence of RBC transfusion during the titration and evaluation periods
- Mean Hb during the total study period
- Intrapatient Hb variability (mean within-patient standard deviation for Hb)
- Frequency of Micera dose level
- safety
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Mircera Arm
Experimental
Once Monthly Mircera
干预措施: Mircera (Drug)
结局指标
主要结局
Number of patients with hemoglobin 10~12 g/dl
时间窗: Visit 0 ~ visit 10 (10 months)
The primary objective of this study is to evaluate the no of patients which maintain the Hb-level between 10.0\~13.0 g/dL during the evaluation period
次要结局
- Hemoglobin stability, Dose adjustment(Visit0~Visit 10 (10 Months))
研究者
Kim Dae Joong
professor
Samsung Medical Center
研究点 (1)
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