A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneous and Intravenous MIRCERA® for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 86
- 主要终点
- Percentage of Participants Maintaining Average Hemoglobin (Hb) Concentration Within the Target Range
研究概览
简要总结
This open label, single arm study will assess the efficacy for long-term maintenance of haemoglobin levels and the safety and tolerability of methoxy polyethylene glycol-epoetin beta [Mircera] in dialysis patients with chronic renal anaemia. Patients on regular long-term haemodialysis or peritoneal dialysis will receive monthly subcutaneous or intravenous Mircera for 6 months. Target sample size is <200 patients.
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 anaemia
- •haemoglobin 10.0-12.0g/dl at screening
- •adequate iron status
- •continuous stable ESA (erythropoietic stimulating agent) therapy for >/= 2 months
- •regular haemodialysis or regular peritoneal dialysis for >/= 3 months
排除标准
- •uncontrolled hypertension
- •haemoglobinopathy
- •anaemia due to haemolysis
- •pure red cell aplasia (PRCA)
研究组 & 干预措施
Single Arm
干预措施: Dialysis (Procedure)
Single Arm
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 (Hb) Concentration Within the Target Range
时间窗: Weeks 1 to 32
Percentage of participants who maintained the Hb concentration within target range (between 10.0 and 12.0 grams per deciliter \[g/dL\]) throughout the treatment period were reported.
次要结局
- Mean Monthly Hb Values(Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8)
- Change in Hb Concentration Between Reference and Treatment Period(Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8)
- Mean Time Participants Spent Having Hb Concentration Within Target Range(Weeks 1 to 32)
- Percentage of Participants Requiring Dose Adjustments(Baseline to Month 1; Month 1 to 2; Month 2 to 3; Month 3 to 4; Month 4 to 5; Month 5 to 6; Month 6 to 7; Month 7 to 8)