An Observational, Non-Interventional Cohort Study to Observe the Efficacy and Use of MIRCERA in the Treatment of Chronic Renal Anaemia in Patients With Chronic Kidney Disease Stage V on Haemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 10
- 主要终点
- Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 2 (Month 1)
研究概览
简要总结
This observational study will evaluate the efficacy and use of Methoxy polyethylene glycol-epoetin beta (Mircera) in participants with Stage V chronic kidney disease on hemodialysis receiving an erythropoietin prior to study entry. Attending physicians should have made the decision of placing the participant on methoxy polyethylene glycol epoetin beta in advance and not related to the study. The therapy will be administered by the attendant treating physician according to specifications in the package insert guidelines and to the routine of the site.
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
- •Participants with chronic renal anemia with Stage V chronic kidney disease on hemodialysis and with a hemoglobin level of 10.0 - 13.0 grams per deciliter (g/dL)
- •Participants had to be receiving an ESA prior to entering the study
- •Female participants of childbearing age had to be using effective contraceptive methods
排除标准
- •As per approved package insert
- •Any contraindication to ESA treatment
研究组 & 干预措施
Chronic Renal Anemia Participants
Participants with chronic kidney disease and who are on hemodialysis and on methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia will be observed for a period of 6-12 months.
干预措施: Methoxy polyethylene glycol epoetin beta (Drug)
结局指标
主要结局
Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 2 (Month 1)
时间窗: Visit 2 (Month 1)
Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 3 (Month 2)
时间窗: Visit 3 (Month 2)
Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 4 (Month 3)
时间窗: Visit 4 (Month 3)
Mean Hemoglobin Value at Visit 6 (Month 5)
时间窗: Visit 6 (Month 5)
Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 5 (Month 4)
时间窗: Visit 5 (Month 4)
Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 6 (Month 5)
时间窗: Visit 6 (Month 5)
Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 7 (Month 6)
时间窗: Visit 7 (Month 6)
Mean Hemoglobin Value at Visit 7 (Month 6)
时间窗: Visit 7 (Month 6)
Mean Hemoglobin Value at Visit 2 (Month 1)
时间窗: Visit 2 (Month 1)
Mean Hemoglobin Value at Visit 3 (Month 2)
时间窗: Visit 3 (Month 2)
Mean Hemoglobin Value at Visit 4 (Month 3)
时间窗: Visit 4 (Month 3)
Mean Hemoglobin Value at Visit 5 (Month 4)
时间窗: Visit 5 (Month 4)
次要结局
- Number of Participants With Dose Adjustments of Methoxy Polyethylene Glycol-Epoetin Beta(Visit 2 (Month 1), Visit 3 (Month 2), Visit 4 (Month 3), Visit 5 (Month 4), Visit 6 (Month 5), Visit 7 (Month 6), Visit 8 (Month 7))
- Mean Methoxy Polyethylene Glycol-Epoetin Beta Dose During the Study(Visit 2 (Month 1), Visit 3 (Month 2), Visit 4 (Month 3), Visit 5 (Month 4), Visit 6 (Month 5), Visit 7 (Month 6))
- Number of Participants Treated According to European Renal Best Practice Guideline (ERBPG) and National Kidney Function (NKF) Kidney Disease Outcomes Quality Initiative (NKF KDOQI) and Mircera Package Insert(Up to 6 months)