NCT01417377已完成不适用
Non-Interventional Study to Document the Efficacy in Routine Clinical Practice of Mircera in Pakistan (NORM)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 6
- 主要终点
- Percentage of Participants Maintaining Hemoglobin (Hb) Levels Between 11-12 Gram Per Deciliter (g/dL) During Final 2 Months of Study
研究概览
简要总结
This observational, prospective, multi-centre, single-arm study will evaluate the efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease previously on treatment with short-acting epoetin alpha. Data will be collected for 6 months.
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, age 18 years or above
- •Chronic kidney disease (CKD) with anemia
- •Patients on dialysis receiving short-acting epoetin (EPO)
- •Serum ferritin level >/=100 ng/ml or transferrin saturation (TSAT) >/=20%
排除标准
- •Patients unwilling to give informed consent
- •Uncontrolled hypertension
- •Transfusion of red blood cells within 8 weeks of the start of Mircera treatment
- •Relevant acute or chronic bleeding history
- •Hemolysis
- •Hemoglobinopathies
- •Pure red cell aplasia
研究组 & 干预措施
Cohort
Mircera
干预措施: Mircera (Drug)
结局指标
主要结局
Percentage of Participants Maintaining Hemoglobin (Hb) Levels Between 11-12 Gram Per Deciliter (g/dL) During Final 2 Months of Study
时间窗: Month 4 up to Month 6
次要结局
- Time to Achieve Hb Level to 11-12 g/dL(Up to 6 months)
- Number of Dose Adjustments Required to Maintain Hb Levels(Up to 6 months)
- Number of Doses of Mircera Taken as Per the Schedule in Summary of Product Characteristics (SmPC)(Up to 6 months)
研究者
研究点 (6)
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