A Non-interventional Study to Assess the Hemoglobin Level Depending on the Comorbidity Index in Chronic Kidney Disease (CKD) Patients Not in Dialysis Treated With Mircera®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 551
- 试验地点
- 105
- 主要终点
- Percentage of Participants With an Increase From Baseline in Hemoglobin Level of Greater Than or Equal to (>/=) 1 g/dL or a Hemoglobin Level Between 10 and 12 g/dL After 9 Months of Treatment Without any Transfusional Recourse
研究概览
简要总结
This prospective, multicenter, observational study will evaluate the impact of comorbidity factors on the hemoglobin level in participants with chronic kidney disease who are not on dialysis and initiated on treatment with methoxy polyethylene glycol-epoetin beta (Mircera). Data will be collected for 9 months after initiation of methoxy polyethylene glycol-epoetin beta 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
- •Participants with chronic kidney disease not on dialysis
- •Treatment-naïve for erythropoiesis-stimulating agents (ESAs), not having received ESAs in the 6 months prior to inclusion in this study
- •Hemoglobin level less then (<)10 grams per deciliter (g/dL) at inclusion
- •Participants for whom the treating physician has decided to initiate treatment with methoxy polyethylene glycol-epoetin beta for medical reasons prior to study start
排除标准
- •Functional renal transplant
- •Current participation in a clinical trial in anemia due to chronic kidney disease
研究组 & 干预措施
Chronic Kidney Disease Participants
Participants for whom the treating physician has decided to initiate treatment with MIRCERA for medical reasons prior to study start, will be observed for 9 months.
干预措施: Methoxy Polyethylene Glycol-Epoetin Beta (Drug)
结局指标
主要结局
Percentage of Participants With an Increase From Baseline in Hemoglobin Level of Greater Than or Equal to (>/=) 1 g/dL or a Hemoglobin Level Between 10 and 12 g/dL After 9 Months of Treatment Without any Transfusional Recourse
时间窗: Baseline, Month 9
次要结局
- Hemoglobin Levels According to Liu Index and Resistance Factors(Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9)
- Average Dose of Mircera in Total Population(Baseline up to 9 months)
- Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in Total Population(Baseline up to 9 months)
- Average Dose of Mircera in Subgroups as Defined by the Comorbidities List Used for the Charlson Comorbidities Index Calculation(Baseline up to 9 months)
- Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) in in Subgroups as Defined by the Comorbidities List Used for the Charlson Comorbidities Index Calculation(Baseline up to 9 months)
- Duration of Treatment With Mircera(Baseline up to 9 months)
- Number of Participants Who Received Concomitant Treatment (Known as Potentially Resistant Factors) for Renal Anemia(Baseline up to 9 month)