NCT01309295已完成不适用
A Prospective Study Evaluating the Efficacy and Safety of Mircera in Patients With CKD in Predialysis and Dialysis.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 主要终点
- Achievement of target hemoglobin (Hb) range of 10-12 g/dL according to Kidney Disease Outcomes Quality Initiative (KDQOI) guidelines
研究概览
简要总结
This prospective observational study will assess the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in clinical practice in patients with chronic kidney disease, in pre-dialysis or on dialysis, initiated on Mircera treatment. Data from each patient will be collected over 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
- •Chronic kidney disease, in pre-dialysis or dialysis
- •Appropriate for treatment with Mircera according to current guidelines and Summary of Product Characteristics
排除标准
- •Anemia due to non-renal causes
- •Pregnant or lactating women
- •Uncontrolled hypertension
- •Known hypersensitivity to methoxy polyethylene glycol-epoetin beta
结局指标
主要结局
Achievement of target hemoglobin (Hb) range of 10-12 g/dL according to Kidney Disease Outcomes Quality Initiative (KDQOI) guidelines
时间窗: 2 years
Maintenance of target Hb range (10-12 g/dL)
时间窗: 2 years
Safety: Incidence of adverse events
时间窗: 2 years
次要结局
- Frequency of visits and laboratory assessments(2 years)
- Effect of compliance to treatment on Hb levels(2 years)
- Dosing pattern in clinical practice, including dose adaptations(2 years)
- Correlation between baseline clinical variables and time on target Hb level(2 years)
研究者
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