NCT01667380已完成不适用
Non-interventional Study on the Use of Mircera in the Treatment of Chronic Renal Anemia in Patients With Chronic Kidney Disease Stages III-IV Not on Dialysis and in Patients on Stage V on Hemodialysis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 主要终点
- Dosage/schedule of Mircera treatment in clinical practice
研究概览
简要总结
This observational study will evaluate the use and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in anemia patients with chronic kidney disease (CKD) stage III-IV not on dialysis or CKD stage V on dialysis. Patients will be followed during 12 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
- •Patients with chronic renal anemia with stage III-IV CKD not on dialysis and who are, in the opinion of the treating physician, not expected at baseline to require dialysis within 12 months
- •Patients with chronic renal anemia with stage V CKD on dialysis
- •No contraindication to ESA treatment
排除标准
- •Uncontrolled hypertension
- •Hypersensitivity to the active substance or any other of the excipients of Mircera and other ESAs
结局指标
主要结局
Dosage/schedule of Mircera treatment in clinical practice
时间窗: approximately 3 years
次要结局
- Proportion of patients with mean Hb level 10-12 g/dL 10 to 12 months after initiation of treatment(approximately 3 years)
- Change in Hb levels(from baseline to Month 12)
研究者
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