A Randomized, Open-label Study Comparing the Pharmacoeconomic (Time and Motion) Benefit of Mircera and Epoetin Alfa in Patients With Chronic Kidney Disease (Stage V) on Dialysis.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 260
- 主要终点
- Time Spent on Anemia Treatment Over Evaluation Period
研究概览
简要总结
This 2 arm study will compare 'time and motion' (provider time spent on anemia management) and effect on hemoglobin (Hb) levels, of methoxy polyethylene glycol-epoetin beta (Mircera) and epoetin alfa, in anemic patients with chronic kidney disease (CKD) on hemodialysis. Patients stable on intravenous (iv) epoetin alfa will be randomized either to receive standard of care therapy (epoetin alfa (iv) 3 times weekly), or to receive Mircera 120-360 micrograms (iv), monthly. After a titration period, average time spent on anemia treatment over a 3 month period will be evaluated. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •adult patients, >=18 years of age;
- •CKD (stage V) on outpatient hemodialysis therapy for >= 3 months;
- •CKD-related anemia treated with epoetin alfa iv 3x/week for >= 3 months;
- •average hemoglobin (Hb) 10-12 g/dL over last 3 months.
排除标准
- •failed renal transplant within 12 months prior to screening;
- •poorly controlled hypertension;
- •previous treatment with Mircera.
研究组 & 干预措施
methoxy polyethylene glycol-epoetin beta
120-360 micrograms (iv) monthly, starting dose
干预措施: methoxy polyethylene glycol-epoetin beta (Drug)
Epoetin Alfa
As prescribed, (iv), 3 times weekly
干预措施: Epoetin alfa (Drug)
结局指标
主要结局
Time Spent on Anemia Treatment Over Evaluation Period
时间窗: Months 5-7
Efficacy and pharmacoeconomics analyses were not performed.
Change in Hemoglobin (Hb) Concentration From Baseline to the Average Over the Evaluation Period
时间窗: Baseline, Months 5-7
Efficacy and pharmacoeconomics analyses were not performed.
次要结局
- Number of Participants Assessed for AEs(Month 1 to 15 day follow up post month 7)
- The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants(Baseline, Month 1 to Month 7)