NCT00680563终止3 期
An Open Label Study of the Safety, Tolerability and Effect on Hemoglobin Levels of Once-monthly Subcutaneous Mircera in Predialysis Patients With Chronic Renal Anemia Not Currently Treated With ESA.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 4
- 主要终点
- Mean change in Hb concentration between baseline and Efficacy Evaluation Period (EEP).
研究概览
简要总结
This single arm study will assess the efficacy and safety of subcutaneous Mircera for the correction and maintenance of hemoglobin levels in predialysis patients with renal anemia who are not currently treated with ESA. Eligible patients will receive monthly subcutaneous injections at an initial recommended dose of 1.2 micrograms/kg. 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;
- •no ESA therapy during previous 3 months;
- •adequate iron status;
- •rapid chronic kidney disease progression.
排除标准
- •transfusion of red blood cells during previous 2 months;
- •poorly controlled hypertension requiring hospitalization in previous 6 months;
- •significant acute or chronic bleeding.
研究组 & 干预措施
1
Experimental
干预措施: methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
结局指标
主要结局
Mean change in Hb concentration between baseline and Efficacy Evaluation Period (EEP).
时间窗: Week 32
次要结局
- Time to achievement of response(Throughout study)
- Percentage of patients whose average Hb concentration is within range 10.0 - 12.0g/dL(Throughout study)
- Mean time spent in Hb range of 10.0 - 12.0g/dL(Throughout study)
- Percentage of patients whose Hb concentration remains within range 10.0-12.0g/dL(Throughout study)
- Percentage of patients requiring dose adjustments; incidence of RBC transfusions; time to initiation of renal replacement therapy.(Throughout study)
研究者
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