An Observational. Non-interventional Study to Observe the Safety and Efficacy of MIRCERA in the Treatment of Chronic Renal Anemia in Maintenance ESA Treated Patients on Haemodialysis (STABILE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 185
- 主要终点
- Number of Participants With Adverse Events (AEs)
研究概览
简要总结
This prospective observational study will evaluate the safety and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic renal anemia on haemodialysis in maintenance ESA treatment. Data will be collected from patients receiving once monthly Mircera according to standard of care and local labelling 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
- •Stage IV chronic kidney disease, on haemodialysis
- •Chronic renal anemia, on maintenance ESA treatment
- •Hemoglobin concentration between 10.0 an 12 g/dL
- •Continuous maintenance epoetin therapy with the same dosing interval during the previous month
排除标准
- •Contraindications to ESA treatment (e.g. hypersensitivity, non-controlled hypertension)
- •Hemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types)
- •Anemia due to hemolysis, pure red cell aplasia
结局指标
主要结局
Number of Participants With Adverse Events (AEs)
时间窗: Up to 12 months
AE: any unfavorable and unintended sign, symptom, or disease associated with use of study drug, regardless of relation to study drug. Pre-existing conditions that worsened and laboratory or clinical tests that resulted in change in treatment or discontinuation from study drug were reported as AEs. Serious AE (SAE): resulted in death, life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect, or was medically significant. Any AE included participants with both serious and non-serious AEs.
次要结局
- Hemoglobin Levels(Baseline; Weeks 8, 16, 24, 48)