NCT01356589已完成不适用
Retrospective Study on Intrapatient VAriabiLity of the Hemoglobin Levels in Anemic CKD Patients in Predialysis (Stage 3-4) and Dialysis (Stage 5) Treated With MIRCERA® (RIVAL Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,288
- 试验地点
- 33
- 主要终点
- Percentage of Participants With at Least One Hemoglobin Cycling
研究概览
简要总结
This retrospective observational study will assess the incidence of hemoglobin cycling in chronic kidney disease (stage 3, 4, and 5) patients with renal anemia treated with Mircera (methoxy polyethylene glycol-epoetin beta). Data will be collected from each patient from a 9-month treatment period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 in predialysis (stage 3 and 4) and dialysis
- •Renal anemia treated with Mircera according to label for at least 9 months before date of signed informed consent
排除标准
- •Participation in an interventional clinical trial within the retrospective observation period
- •Contraindications to Mircera administration as per label or judged by the investigator
结局指标
主要结局
Percentage of Participants With at Least One Hemoglobin Cycling
时间窗: 9 months
Hemoglobin cycling was defined as 1 or more cycles of oscillation in hemoglobin with an amplitude of greater than or equal to (\>=) 1.5 gram per deciliter (g/dL) and a duration \>=8 weeks.
次要结局
- Percentage of Participants With Type 2 Diabetes Who Experienced at Least 1 Hemoglobin Cycling(9 months)
- Number of Full Hemoglobin Cycles Per Participant(9 months)
研究者
研究点 (33)
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