NCT01690455已完成不适用
Non-interventional Study to Assess the Efficacy of Mircera for Renal Anemia Correction in Dialysis Patients in Everyday Clinical Practice in Poland.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 247
- 主要终点
- Proportion of patients who achieve a hemoglobin level of >/=10 g/dl
研究概览
简要总结
This observational, multi-center study will evaluate the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in renal anemia correction in dialysed patients in daily clinical practice. Patient will receive Mircera according to local summary of product characteristics. Data will be collected for 12 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, >/=18 years of age
- •Adequate iron status
- •Signed informed consent form
排除标准
- •Anemia due to non-renal causes
- •Where investigator considers the patient unsuitable for inclusing for other reasons (e.g. severe co-morbidities as active bleeding, infections or cancer)
- •Pregnant or lactating female patients
- •Any contraindications against treatment with Mircera (according to local Summary of Product Characteristics)
结局指标
主要结局
Proportion of patients who achieve a hemoglobin level of >/=10 g/dl
时间窗: 12 months
次要结局
- Safety: incidence of adverse events(12 months)
研究者
相似试验
已完成
不适用
An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) as Maintenance Treatment in Patients With Chronic Renal Anemia on HaemodialysisAnemia, Kidney Disease, ChronicNCT01422824Hoffmann-La Roche185
已完成
不适用
An Observational Study of Mircera in Patients With Chronic Renal Anemia on Dialysis (CKD Stage V) or Not on Dialysis (CKD Stage III-IV)AnemiaNCT01667380Hoffmann-La Roche78
已完成
不适用
An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Patients With Chronic Kidney Disease in Pre-Dialysis or DialysisAnemia, Kidney Disease, ChronicNCT01309295Hoffmann-La Roche250
已完成
不适用
An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Anemic Patients With Chronic Kidney Disease (NORM)AnemiaNCT01417377Hoffmann-La Roche22
已完成
不适用
OPTIMA: An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Participants With Chronic Kidney Disease Stages 3 and 4 Not on DialysisAnemiaNCT01902628Hoffmann-La Roche437