A Single Arm Open Label Study to Assess the Efficacy, Safety and Tolerability of Once Monthly Administration of Subcutaneous C.E.R.A. for the Maintenance of Haemoglobin Levels in Pre-dialysis Patients With Chronic Renal Anaemia
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 29
- 主要终点
- Percentage of Participants Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Their Reference Hemoglobin and Within the Target Range
研究概览
简要总结
This single arm study will assess the efficacy, safety and tolerability of subcutaneous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) for maintenance of hemoglobin levels in pre-dialysis participants with chronic renal anemia. Participants currently receiving maintenance treatment with subcutaneous darbepoetin alfa will receive monthly subcutaneous injections of C.E.R.A. with the starting dose of 120, 200 or 360 micrograms (mcg) derived from the dose of darbepoetin alfa or epoetin alfa in the week preceding study start.
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
- •Chronic renal anemia
- •Hemoglobin concentration between 10.5 gram per deciliter (g/dL) and 12.5 g/dL
- •Adequate iron status (serum ferritin greater than [>] 100 nanogram per milliliter and Transferrin Saturation >20 percent [%] or hypochromic red cells less than [<] 10%)
- •Continuous subcutaneous maintenance darbepoetin alfa therapy with same dosing interval during previous 2 months
排除标准
- •Transfusion of red blood cells during previous 2 months
- •Poorly controlled hypertension requiring hospitalization or interruption of darbepoetin alfa treatment in previous 6 months
- •Acute or chronic bleeding
- •Active malignant disease (except non-melanoma skin cancer)
研究组 & 干预措施
C.E.R.A.
干预措施: Methoxy polyethylene glycol-epoetin beta (C.E.R.A.) (Drug)
结局指标
主要结局
Percentage of Participants Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Their Reference Hemoglobin and Within the Target Range
时间窗: Week 17 up to Week 24
Percentage of participants maintaining the mean hemoglobin concentration within +/- 1.0 g/dL of their reference hemoglobin value and within the target range of 10.5 to 12.5 g/dL during the efficacy evaluation period (EEP) was reported. The reference hemoglobin value was defined as the mean of the 5 assessments recorded during the stability verification period (SVP) at Weeks -4, -3, -2, -1 and 0. The mean hemoglobin concentration for each individual participant during the EEP (Week 17 to Week 24) was estimated as a time adjusted average.
次要结局
- Change in Hemoglobin Concentration Between Reference (SVP) and EEP(Week 17 up to Week 24)
- Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range During EEP(Week 17 up to Week 24)
- Mean Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP(Week 17 up to Week 24)
- Percentage of Participants Requiring Any Dose Adjustment(Week 1 up to Week 16 and Week 17 up to Week 24)
- Percentage of Participants With Red Blood Cell Transfusion During the Study(Week 0 up to Week 24)
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(Week 0 up to Week 24)