An Open-Label Study of the Tolerability and Flexibility of Multi-Dose NeoRecormon Administered by Reco-Pen in Pre-Dialysis Patients With Chronic Renal Anemia.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 58
- 主要终点
- Percentage of participantss who change to once weekly NeoRocormon
研究概览
简要总结
This study will evaluate the tolerability, and effect on quality of life, in patients receiving multi-dose NeoRecormon administered by RecoPen in predialysis patients with chronic renal anemia. The anticipated time on study treatment is 10 months, and the target sample size is 60 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients 18-65 years of age
- •Chronic renal failure (Stages I-III)
- •No previous epoetin therapy
排除标准
- •Poorly controlled hypertension
- •History or evidence of malignancy
- •Relevant acute or chronic bleeding (requiring therapy) within 3 months before study drug
- •Women who are pregnant or breastfeeding
研究组 & 干预措施
Epoetin Beta
Patients will be administered 3 times (X) 30 International unis per kilogram(IU/Kg body weight per week of eopetin beta subcurtaneously using the device RecoPen. The dosage could be increased every 4 weeks by 3 X20 IU/Kg.
干预措施: Epoetin Beta (Drug)
结局指标
主要结局
Percentage of participantss who change to once weekly NeoRocormon
时间窗: 10 months
Percentage of participants who changed dose during treatmnent
时间窗: 10 months
Percentage of participants who withdrew due to inability to use RecoPen
时间窗: 10 months
Percentage of participants with local intolerabilities (pain/allergic reactions)
时间窗: 10 months
次要结局
- Quality of life evaluated by the Short Form 36(10 months)