A Single Arm Open Label Multicenter Interventional Study to Assess the Efficacy, Safety, and Tolerability of Every 4 Weeks Administration of Subcutaneous C.E.R.A. for the Treatment of Chronic Renal Anemia in Diabetic Nephropathy With Chronic Kidney Disease Stages III-IV Not on Dialysis, Not Currently Treated With ESA.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 14
- 主要终点
- Mean time taken to achieve target hemoglobin (Hb) levels range (10-12 g/dL) During Efficacy Evaluation Period (EEP)
研究概览
简要总结
This single arm, open label study will assess the efficacy, safety and tolerability of methoxy polyethylene glycol-epoetin beta for the treatment of chronic renal anemia in participants with chronic kidney disease (CKD) secondary to diabetes. Participants who are not on dialysis and not currently treated with erythropoiesis stimulating agents (ESAs) will receive methoxy polyethylene glycol-epoetin beta subcutaneously every 4 weeks (Q4W). The starting dose of 1.2 microgram/kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta will be adjusted according to hemoglobin levels. Anticipated time on study treatment is 28 weeks.
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
- •Diabetic nephropathy
- •Chronic renal anemia with stage III-IV CKD
- •Not on dialysis and not expected to require dialysis within the next 6 months
- •Not receiving any ESA in the 2 months prior to study
- •Adequate iron status
排除标准
- •Transfusion of red blood cells during the previous 2 months
- •Known or clinical suspicion of pure red cell aplasia
- •Hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
- •Haemoglobinopathy
- •Significant acute or chronic bleeding
研究组 & 干预措施
Methoxy polyethylene glycol-epoetin beta
Participants will receive 1.2 mcg/kg methoxy polyethylene glycol-epoetin beta given in monthly doses at each visit. Dose will be measured on the basis of the participants Hb level during the study period. The dose administration will be the nearest possible dose using the prefilled syringes containing 50, 75 and 100 mcg/kg Q4W.
干预措施: Methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
结局指标
主要结局
Mean time taken to achieve target hemoglobin (Hb) levels range (10-12 g/dL) During Efficacy Evaluation Period (EEP)
时间窗: EEP (Week 17 up to Week 24)
Change in Hb Concentration Between Baseline and EEP
时间窗: Baseline (Week -2 up to Week 0); EEP (Week 17 up to Week 24)
Percentage of Participants Maintaining Hb Concentration Within the Target Range (10-12 g/dL) During EEP
时间窗: EEP: (Week 17 up to Week 24)
次要结局
- Percentage of Participants With Adverse Events(Baseline (Week -2 up to Week 0) to Week 28)
- Percentage of Participants With Red Blood Cell Transfusion During Treatment Period(Week 0 up to Week 24)
- Percentage of Participants with anti-epoetin antibodies(Baseline (Week-2 up to Week 0) up to Week 28)
- Short Form-36 Health Survey (SF-36) score(Week 0 to Week 24)