A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneous Mircera® for the Maintenance of Haemoglobin Levels in Patients With Chronic Renal Anaemia Who Are Not on Dialysis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 191
- 试验地点
- 10
- 主要终点
- Percentage of Participants Maintaining Average Hemoglobin Concentration Within the Target Range During the Efficacy Evaluable Period (EEP)
研究概览
简要总结
This single arm study will assess the efficacy, safety and tolerability of once monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in patients with chronic renal anemia not on dialysis.Patients will receive sc Mircera at a starting dose of 100, 120, 200 or 360 micrograms every 4 weeks, calculated from the last weekly dose of ESA previously administered. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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;
- •chronic renal anemia;
- •continuous maintenance ESA therapy with the same dosing interval during the previous month, and no change in totally weekly dose.
排除标准
- •transfusion of red blood cells during previous 2 months;
- •poorly controlled hypertension;
- •significant acute or chronic bleeding;
- •active malignant disease (except non-melanoma skin cancer).
研究组 & 干预措施
1
干预措施: methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
结局指标
主要结局
Percentage of Participants Maintaining Average Hemoglobin Concentration Within the Target Range During the Efficacy Evaluable Period (EEP)
时间窗: EEP (Weeks 17 to 24)
The target hemoglobin was defined as the mean of the three assessments recorded at Weeks -4, -2, and 0 (Stability Verification Period \[SVP\]). EEP was an 8 week period from Weeks 17 to 24. The 95 percent (%) confidence interval (CI) was estimated using Clopper-Pearson.
次要结局
- Average Dose of Mircera Per Month(Weeks 0-4, 4-8, 8-12, 12-16, 16-20, and 20-24)
- Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 10.0 to 12.0 g/dL Throughout the EEP(EEP (Weeks 17 to 24))
- Percentage of Participants Who Required Dose Adjustments During Dose Titration Period (DTP) and EEP(Weeks 1 to 24)
- Time Spent in Hemoglobin Range of 10.0 to 12.0 g/dL During DTP and EEP(Weeks 1 to 24)
- Change in Hemoglobin Concentration Between SVP and the EEP(SVP (Baseline), and EEP (Weeks 17 to 24))