An Open Label Study to Assess the Maintenance of Hemoglobin Levels, Safety and Tolerability of Once Monthly Administration of Mircera in Hemodialysis Patients With Chronic Renal Anemia.
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Percentage of patients maintaining average Hb concentration within target range during evaluation period
研究概览
简要总结
This single arm study will assess the long-term maintenance of hemoglobin levels, safety and tolerability of once-monthly intravenous administration of Mircera in hemodialysis patients with chronic renal anemia. Patients currently receiving darboepoetin alfa or epoetin alfa maintenance treatment will receive intravenous Mircera at a starting dose of 120, 200 or 360 micrograms/4 weeks (based on the ESA dose administered on week-1). Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10.5-12.5g/dL. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •adult patients, >=18 years of age;
- •chronic renal anemia;
- •regular long-term hemodialysis therapy with the same mode of dialysis for >=3 months;
- •continuous iv or sc maintenance ESA treatment during previous 2 months.
排除标准
- •transfusion of red blood cells during previous 2 months;
- •significant acute or chronic bleeding, such as overt gastrointestinal bleeding;
- •active malignant disease (except non-melanoma skin cancer).
研究组 & 干预措施
1
干预措施: methoxy polyethylene glycol-epoetin beta (Drug)
结局指标
主要结局
Percentage of patients maintaining average Hb concentration within target range during evaluation period
时间窗: Weeks 17-24
次要结局
- Change in Hb concentration between reference and evaluation period; mean time spent in, and percentage of patients maintaining Hb within target range(Weeks 17-24)
- Dose adjustments; RBC transfusions(Throughout study)
- AEs, laboratory parameters, vital signs(Throughout study)