NCT01974271已完成不适用
IMPACT OF COMORBITIES ON HEMOGLOBIN STABILITY IN CHONIC KIDNEY DISEASE PATIENTS ON DIALYSIS TREATED WITH C.E.R.A
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 661
- 主要终点
- Percentage of patients with a variation of Hb level of +/- 1 g/dL between the first Mircera injection and Month 6
研究概览
简要总结
This prospective, multicenter, observational study will evaluate the impact of comorbidities on hemoglobin stability in chronic kidney disease patients on dialysis treated with Mircera (methoxy polyethylene glycol-epoetin beta). Eligible patients will be followed for 6 months of treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 kidney disease patients on hemodialysis or hemodiafiltration for at least 3 months
- •Previously treated with an erythropoietin stimulating agent (ESA)
- •Patient for whom the investigator decided to initiate treatment with Mircera for medical reasons
- •Last hemoglobin level before initiation of Mircera within the range of 10-12 g/dL
排除标准
- •Current participation in a clinical trial on renal anemia
结局指标
主要结局
Percentage of patients with a variation of Hb level of +/- 1 g/dL between the first Mircera injection and Month 6
时间窗: 6 months
次要结局
- Monthly dose of Mircera(6 months)
- Percentage of patients with Hb value within the range of 10 - 12 g/dL(6 months)
- Change in Hb level(from baseline to Month 6)
- Safety: Incidence of adverse events(6 months)
研究者
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