A Single Arm, Open-Label, Multicentre Study to Assess the Maintenance of Haemoglobin Levels With Once Monthly Subcutaneous Administration of C.E.R.A (Continuous Erythropoietin Receptor Activator) in Patients With Chronic Kidney Disease on Peritoneal Dialysis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 52
- 主要终点
- Percentage of Participants Who Maintained Average Hb Value Within Target Range During the EEP
研究概览
简要总结
This single-arm study will assess the efficacy and safety of monthly administration of SC Mircera for the maintenance of hemoglobin levels in participants with chronic kidney disease on peritoneal dialysis. Participants currently receiving maintenance treatment with SC erythropoietin stimulating agents (ESAs) will receive monthly SC injections of Mircera, with the starting dose derived from the last weekly ESA they had been receiving.
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
- •Adults greater than or equal to (≥) 18 years of age
- •Chronic kidney disease-related anemia on peritoneal dialysis for ≥3 months
- •Continuous SC maintenance stable ESA therapy for 4 weeks prior to study start
排除标准
- •Transfusion of red blood cells during previous 8 weeks
- •Poorly controlled hypertension requiring interruption of ESA treatment in previous 6 months
- •Significant acute or chronic bleeding during previous 8 weeks
研究组 & 干预措施
Mircera in Renal Anemia
Participants will receive SC methoxy polyethylene glycol-epoetin beta (Mircera) every 4 weeks for a total of 48 weeks in this single-arm study. The first dose of 120 or 200 micrograms (mcg) will be determined by the dose of ESA received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within the target range.
干预措施: Methoxy polyethylene glycol-epoetin beta (Drug)
结局指标
主要结局
Percentage of Participants Who Maintained Average Hb Value Within Target Range During the EEP
时间窗: Weeks 16 to 24
Participants provided pre-dose blood samples for Hb monitoring while on treatment with Mircera/CERA. The average Hb during the EEP (Weeks 16 to 24) was calculated per participant and assessed against the target range. The percentage of participants who had average Hb during the EEP in the target range (10 to 12 g/dL) was determined as the primary endpoint. The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds.
次要结局
- Percentage of Participants With Hb Values Within Target Range During the EEP(Weeks 16 to 24)
- Change in Hb Value From Baseline to the EEP(Baseline and Weeks 16 to 24)
- Time Spent in the Target Range for Hb During the EEP and the Overall Treatment Period(Weeks 16 to 24 and Weeks 0 to 48)
- Percentage of Participants With Hb Value Within Plus/Minus (±) 1 g/dL of Reference Hb and Within the Target Range by Study Visit(Baseline and Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48)
- Percentage of Participants With Cycles or Excursions(Weeks 4 to 44)
- Percentage of Participants With Up Excursions(Weeks 4 to 16, Weeks 16 to 24, Weeks 24 to 44)
- Percentage of Participants With Down Excursions(Weeks 4 to 16, Weeks 16 to 24, Weeks 24 to 44)
- Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA(Weeks 4 to 20, Weeks 24 to 48, Weeks 4 to 48)
- Number of Dose Adjustments of Mircera/CERA(Weeks 4 to 20, Weeks 24 to 48, Weeks 4 to 48)
- Absolute Change in Dose of Mircera/CERA by Study Week(Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48)
- Percent Change in Dose of Mircera/CERA by Study Week(Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48)
- Percentage of Participants Requiring Blood Transfusions(Weeks 0 to 48)