Single-arm, Open Study to Investigate the Efficacy, Safety and Tolerability of Monthly Subcutaneously Administered C.E.R.A. in Patients With Renal Anemia Not Yet Subject to Dialysis and Not Yet Permanently Treated With ESAs
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 184
- 主要终点
- Percentage of Participants With Both Hemoglobin Values of the Evaluation Phase in the Range of 11-12 Grams Per Deciliter (g/dL)
研究概览
简要总结
This single arm study will assess the efficacy and safety of subcutaneous Mircera for correction of anemia in participants with chronic kidney disease who are not treated with erythropoiesis stimulating agent (ESA) and not on dialysis. Eligible participants will receive Mircera by monthly subcutaneous injections. The initial dose, based on body weight, will be 1.2 micrograms/kilogram (mcg/kg). The anticipated time on study treatment is 9-11 months, and the target sample size is 100-500 individuals.
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 value less than or equal to (<=) 10.5 grams/deciliter (g/dL).
排除标准
- •prior ESA therapy during previous 3 months;
- •acute or chronic bleeding requiring therapy during previous 2 months;
- •transfusion of red blood cells during previous 2 months;
- •active malignant disease (except non-melanoma skin cancer).
研究组 & 干预措施
Methoxy polyethylene glycol-epoetin beta
Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously once a month. The starting dose will be 1.2 mcg/kg of body weight. Further dose adjustments will be performed during the study depending on the hemoglobin value. Total duration of treatment will be 9 months for all participants in the study and up to 11 months for participants who will be shifted to the dialysis.
干预措施: Methoxy polyethylene glycol-epoetin beta (Drug)
结局指标
主要结局
Percentage of Participants With Both Hemoglobin Values of the Evaluation Phase in the Range of 11-12 Grams Per Deciliter (g/dL)
时间窗: Evaluation phase (Months 8 and 9)
Participants with both hemoglobin values of the evaluation phase (Months 8 and 9, i.e., Study Days 200-260, values were at least 21 days apart) in the range of 11-12 g/dL were classified as responder. Participants who received transfusion of erythrocytes between Study Day 139 and 260, or with at least one value missing or outside the range were classified as non-responder for the hemoglobin-range concerned.
Percentage of Participants With Both Hemoglobin Values of the Evaluation Phase in the Range of 11-13 g/dL
时间窗: Evaluation phase (Months 8 and 9)
Participants with both hemoglobin values of the evaluation phase (Months 8 and 9, i.e., Study Days 200-260, values were at least 21 days apart) in the range of 11-13 g/dL were classified as responder. Participants who received transfusion of erythrocytes between Study Day 139 and 260, or with at least one value missing or outside the range were classified as non-responder for the hemoglobin-range concerned.
Change From Baseline in Hemoglobin Value to the Evaluation Phase
时间窗: Baseline, evaluation phase (Months 8 and 9)
The change from the baseline hemoglobin value to the mean hemoglobin value of the evaluation phase was only calculated if both the baseline value and the mean of the evaluation phase (mean of Months 8 and 9) were available. In case of only one available hemoglobin value within the evaluation phase, that single value replaced the mean.
次要结局
- Time to Increase of Hemoglobin Value to Over 11 g/dL(Baseline to Month 9)
- Total Number of Dose Adjustments(Baseline until Month 8)
- Total Number of Red Blood Cell (RBC) Transfusions(Baseline to Month 9)
- Duration of Hemoglobin Values in the Range of 11-12 g/dL(Baseline to Month 9)
- Duration of Hemoglobin Values in the Range of 11-13 g/dL(Baseline to Month 9)