A Single Arm Open Label Study to Assess Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneously C.E.R.A. for the Maintenance of Hemoglobin Levels in Patients With Chronic Renal Anemia Not on Dialysis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 23
- 主要终点
- Percentage of Participants Maintaining Hb Concentration Within +/-1 Gram Per Deciliter (g/dL) of Their Reference Hb and Between 10.5 to 12.5 g/dL Throughout the Efficacy Evaluation Period (EEP)
研究概览
简要总结
This single arm study will assess the efficacy and safety of subcutaneous C.E.R.A. when administered for the maintenance of hemoglobin levels in participants with chronic renal anemia, not on dialysis. Participants currently receiving maintenance treatment with subcutaneous darbepoetin alfa or epoetin beta will receive monthly injections of C.E.R.A., with the starting dose (120, 200 or 300 micrograms [mcg] subcutaneously [SC]) derived from the dose of darbepoetin alfa or epoetin beta they were receiving 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
- •Stable darbepoetin alfa or epoetin beta therapy for past 8 weeks
排除标准
- •Transfusion of red blood cells during previous 8 weeks
- •Poorly controlled hypertension requiring interruption of epoetin treatment in previous 6 months
- •Acute or chronic bleeding requiring therapy within previous 8 weeks
研究组 & 干预措施
methoxy polyethylene glycol-epoetin beta
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 Hb Concentration Within +/-1 Gram Per Deciliter (g/dL) of Their Reference Hb and Between 10.5 to 12.5 g/dL Throughout the Efficacy Evaluation Period (EEP)
时间窗: EEP (Weeks 16 to 24)
The reference Hb value was taken as the time adjusted average of all Hb assessments during the Stability Verification Period (SVP) (Week -4 to Week 0). EEP was from Week 16 to Week 24.
次要结局
- Percentage of Participants With Dose Adjustment(Baseline up to Week 20)
- Mean Change in Hb Concentration Between SVP and the EEP(SVP (Week -4 to Week 0) and EEP (Week 16 to Week 24))
- Percentage of Participants Maintaining Hb Concentration Within Hb Range 10.5 to 12.5 g/dL During the EEP(EEP (Weeks 16 to 24))
- Mean Time Spent in Hb Range of 10.5 to 12.5 g/dL During the EEP(EEP (Weeks 16 to 24))
- Percentage of Participants With Blood Transfusion(Baseline up to Week 28)