NCT01111630已完成4 期
Compare the Hemoglobin and Hematocrit Variability Between Once & Three Times Weekly Erythropoietin Therapy for the Anemia in Patients With Maintenance Dialysis
JW Pharmaceutical1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The hemoglobin variability between once & three times weekly administration
研究概览
简要总结
The purpose of this study is to compare the hemoglobin and hematocrit variability between once and three times weekly erythropoietin therapy for the anemia in patients with maintenance dialysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and
- •Dialysis for at least 3 months.
- •Epoetin treatment for the last 3 months.
- •Baseline hemoglobin (Hb) value of >= 9.0 g/dL and < 13.0 g/dL.
- •Baseline mean weekly epoetin maintenance dose ≤ 12,000 IU
- •Patients who agree to participate in this study in writing.
排除标准
- •Hemoglobinopathies, i.e. sickle cell disease, thalassemia of all types.
- •Hemolysis as defined
- •Gastrointestinal bleeding necessitating treatment (medication, transfusion) within the last 3 months.
- •Patients with uncontrolled hypertension.
- •Acute infection of unstable systemic inflammatory disease.
- •Current malignant disease.
- •High likelihood of early withdrawal or interruption of the study (e.g. severe diseases within the last 3 months, such as myocardial infarction, unstable angina, stroke, deep venous thrombosis).
- •Life expectancy below 12 months.
- •Planned elective surgery during the study period.
- •Blood transfusions within the last 3 months.
- •Pregnancy and lactation.
- •Other conditions regarded as unsuitability by investigator.
研究组 & 干预措施
once weekly
Experimental
干预措施: recomon (Epoetin Beta) (Drug)
three times weekly
Active Comparator
干预措施: recomon (Epoetin Beta) (Drug)
结局指标
主要结局
The hemoglobin variability between once & three times weekly administration
时间窗: 24 weeks
次要结局
- Drop out rate during dose fix period(24 weeks)
- Weekly oetin-beta maintenance dose between once & three times weekly administration(24 weeks)
- The hematocrit variability between once & three times weekly administration(24 weeks)
- Variability of Hb and Hct during dose fix period(24weeks)
- Mean value of Hb and Hct between once & three times weekly administration(24 weeks)
- Mean value of Hb and Hct during dose fix period(24 weeks)
研究者
研究点 (1)
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