Efficacy of C.E.R.A. for Correction of Anemia and Maintenance of the Hb Levels in CKD Patients on Dialysis , Treated According to Routine Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 7
- 主要终点
- Mean Age of Participants Treated With C.E.R.A
研究概览
简要总结
This observational study will evaluate the use in clinical practice and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease patients on dialysis receiving Mircera for the treatment of chronic renal anemia. Eligible patients will be followed for 24 weeks.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, 18 to 65 years of age, inclusive
- •Patients with chronic kidney disease on dialysis
- •ESA naïve with Hb < 10 g/dL, or on treatment with ESAs other than Mircera and Hb within the target range of 10-12 g/dL
- •Adequate irons status as judged by the treating physician
排除标准
- •Hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
- •Clinically significant concomitant disease or disorder as defined by protocol
- •Clinical suspicion of pure red cell aplasia (PRCA)
- •Planned elective surgery during the study period , except for cataract surgery or vascular access surgery
- •Transfusion of red blood cells in the previous 2 months
- •Pregnant women
- •Contraindications for Mircera according to local prescribing information or as judged by the investigator
结局指标
主要结局
Mean Age of Participants Treated With C.E.R.A
时间窗: Baseline (Week 0)
Age was calculated on screening/Baseline visit day by using formula: Age = (Screening visit date - Date of birth)/365.25
Mean Weight of Participants Treated With C.E.R.A
时间窗: Baseline (Week 0)
Weight of the participants was measured at the Baseline and summarized with descriptive statistics.
Number of Participants With Co-morbidity Treated With C.E.R.A
时间窗: Up to Week 24
Co-morbidity is the presence of one or more additional disorders (or diseases) co-occurring with a primary disease or disorder; or the effect of such additional disorders or diseases. Co-morbid participants with renal and urinary disorders, vascular disorders, metabolism and nutrition disorders were reported.
Mean Time Required to Achieve Target Hemoglobin Range
时间窗: Up to Week 24
The target range of hemoglobin (Hb) was 10-12 gram/deciliter (g/dL). Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time - visit date of first dosing) + 1
Percentage of Participants Achieved Target Range of Hemoglobin
时间窗: Up to Week 24
The target range of Hb was 10-12 gram/deciliter (g/dL). Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time - visit date of first dosing) + 1. The percentage of participants with Hb \< 10 g/dL at enrollment, achieving the target range of hemoglobin 10-12 g/dL was reported.
Percentage of Participants Who Had Received Treatment With Other Erythropoiesis-Stimulating Agents Maintaining Hb Level Within 1 Gram/Deciliter of Baseline Value During Study Period in Participants.
时间窗: Up to Week 24
Percentage of participants maintaining Hb level within 1 g/dL of baseline value during study period who had received treatment with other Erythropoiesis-Stimulating Agents (ESAs) were reported.
次要结局
- Mean Time Spent by Participants in the Hb Target Range(Up to Week 24)
- Evaluation of Route of Administration for C.E.R.A(Up to Week 24)
- Number of Participants Achieving Hb Target Range (10-12 Hb g/dL) at Least Once During the Study(Up to Week 24)
- Evaluation of Dose Per Injection of C.E.R.A(Up to Week 24)
- Number of Participants Received Concomitant Medications(Up to Week 24)