A Single Arm Open Label Interventional Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous Methoxy-polyethylene Glycol-epoetin Beta for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 33
- 试验地点
- 12
- 主要终点
- Proportion of Participants Maintaining Average Haemoglobin During the Efficacy Evaluation Period Within the Target Range (10-12 g/dl)
研究概览
简要总结
This open-label single-arm study will evaluate the efficacy, safety and tolerability of methoxy polyethylene glycol epoetin beta on long-term maintenance of haemoglobin levels in patients with chronic renal anaemia. Patients will receive methoxy polyethylene glycol-epoetin beta intravenously once monthly at initial doses of either 120 micrograms or 200 micrograms or 360 micrograms in the titration phase of 16 weeks with a potential dose adjustment in the evaluation phase of 8 weeks. The anticipated time on study treatment is 24 weeks. The target sample size is 50-100 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
- •Adults >/=18 years of age
- •Chronic renal anaemia
- •Haemoglobin concentration between 10 and 12 g/dL at screening
- •Adequate iron status
- •Continuous intravenous maintenance short-acting therapy with same dosing interval for 8 weeks prior to screening
- •Regular long-term haemodialysis therapy for at least 12 weeks prior to screening
排除标准
- •Change in haemoglobin concentration >/=2 g/dL during screening
- •Transfusion of red blood cells less than 8 weeks prior to screening
- •Poorly controlled hypertension
- •Relevant acute or chronic bleeding requiring treatment less than 8 weeks prior to screening
- •Active malignant disease
- •Haemolysis
- •Haemoglobinopathies
研究组 & 干预措施
Mircera
干预措施: methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
结局指标
主要结局
Proportion of Participants Maintaining Average Haemoglobin During the Efficacy Evaluation Period Within the Target Range (10-12 g/dl)
时间窗: Up to Week 24
The proportion of participants with their mean haemoglobin (Hb) concentration (g/dL) within the target range during the efficacy evaluation period was assessed. The target range is the reference Hb not \>12 g/dL and not \< 10 g/dL.
次要结局
- Number of Participants With Adverse Events and Serious Adverse Events(Up to Week 28)
- Proportion of Participants Maintaining Haemoglobin Concentration Within the Haemoglobin Range 10-12g/dL Throughout the Efficacy Evaluation Period(Up to Week 24)
- Mean Change in Haemoglobin Concentration From Screening Period and Efficacy Evaluation Period(Up to Week 24)
- Mean Time Spent by Participants in the Haemoglobin Range of 10 - 12 g/dL During the Efficacy Evaluation Period(Up to Week 24)
- Mean Monthly Dose of Methoxy Polyethylene Glycol-epoetin Beta During the Dose Titration and Evaluation Periods(Baseline, Week 4, Week 8, Week 12, Week 16, and Week 20)
- Mean Number of Months Per Participant Requiring Dose Adjustment During the Dose Titration and Evaluation Periods(Up to Week 24)
- Number of Participants With Marked Laboratory Abnormalities(Up to Week 28)