An Open-Label Study of the Optimization of Anemia Management of EPREX (Epoetin Alfa) in Predialysis Patients With Chronic Renal Failure
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 292
- 主要终点
- Hemoglobin change - reach of target Hb levels (measured at Visit 1, 2, 3, 4)
研究概览
简要总结
The purpose of the study is to evaluate the effectiveness, safety and clinical outcome of Epoetin alfa with dosing regime in accordance with Summary of Product Characteristics in the treatment of anemia in predialysis.
详细描述
Open-label, non-randomized, multicenter study for anemic patients with hemoglobin <or=11 g/dl. The dose of epoetin alfa is the routine dosage regimen and is in accordance of the approved SmPC. That's why the study had in general two phases - first period: subcutaneous administration and second period:intravenous administration. The evaluation is made in 4 visits:baseline, 2 month (Visit 1), 4 month (Visit 2), 6 month (Visit 3), 9 month (Visit 4). Echographic evaluation - on baseline visit, Visit 3 and Visit 4.Baseline visit - weight, arterial pressure, Hemoglobin, Hematocrit, Erythrocytes, Middle Cells Volume, Middle Cells Hemoglobin, Middle Cells Hemoglobin Concentration, Transferrin, Creatinine, Clerans, Visit1, Visit 2, Visit 3, Visit 4 - Hemoglobin, Hematocrit, Erythrocytes, Middle Cells Volume, Middle Cells Hemoglobin, Middle Cells Hemoglobin Concentration. The dosage is in routine dosing regimen, the starting dose of epoetin alfa is 50 Units/kg body weight. The maintaining dose depends on hematological results. Administration - subcutaneous (during the first period), intravenous (second period). Duration of the study - 9 months.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Hb<or= 11g/dl
- •Females - using adequate contraceptive method
排除标准
- •Patients with uncontrolled or severe cardiovascular disease, including recent myocardial infarction, uncontrolled hypertension or congestive heart failure
- •treatment within the previous 6 months with epoetin alfa or any erythropoietin, known hypersensitivity to the product or to any of the ingredients
- •patient not in line with the approved SmPC
结局指标
主要结局
Hemoglobin change - reach of target Hb levels (measured at Visit 1, 2, 3, 4)
次要结局
- Prevention of left ventricular hypertrophy (measured at Visit 3 and 4)
