NCT02490514已完成不适用
Mircera In Patients With CKD Stages III-IV Not On Dialysis: Observational, Non-interventional Cohort Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 153
- 主要终点
- Percent Of Participants Who Reached And Maintained Target Hemoglobin Values During Treatment
研究概览
简要总结
This open-label, non-randomized, retrospective-prospective, non-interventional study will evaluate the efficacy and safety of Mircera in patients with stage III-IV chronic kidney disease (CKD) not on dialysis. Patients will receive open-label treatment with Mircera for 12 months at a dose to be determined by the investigator.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with stage II-IV CKD not on dialysis, including renal transplant patients, who are receiving erythropoiesis-stimulating agent (ESA) treatment or are ESA-naive
- •Patients who will not require dialysis within 12 months after the start of Mircera therapy
- •Patients whose life expectancy is greater than 12 months after Mircera initiation
- •Patients >/= 18 years and </= 75 years of age
- •Patients who are female and of childbearing potential must be using effective contraception methods
- •Patients with no contra-indications to ESA treatment (for example, hypersensitivity, non-controlled hypertension and others according to the local SmPC)
- •Patients who have given written informed consent where local regulations allow or require it
排除标准
- •Patients with stage I-II or stage V CKD
- •Poorly controlled hypertension
- •Active malignant disease
结局指标
主要结局
Percent Of Participants Who Reached And Maintained Target Hemoglobin Values During Treatment
时间窗: 12 months
次要结局
- Percent Of Participants Treated With Iron Supplements(12 months)
- Mircera Dose At Start And End Of Treatment(12 months)
- Hb Levels At Start And End Of Treatment(12 months)
- Time To Achieve Response To Mircera(12 months)
- Percent of Participants Who Required Transfusion At Start And End Of Treatment(12 months)
研究者
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