EUCTR2004-000983-29-SE进行中（未招募）不适用
Effectiveness of a once weekly subcutaneous epoetin beta treatment in hemodialysis patients. - Alfa2Beta
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 700
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Informed consent
- •- Stable hemodialysis patients with renal anemia treated with iv darbepoetin alfa once weekly for at least 12 weeks prior to study enrollment
- •- Stable Hb-values (11 – 13 g/dL, determined before hemodialysis) in the last 12 weeks prior to enrollment
- •- Sample for anti erythropoietin-antibody test taken at baseline
- •- Sample for Vit B12 and folic acid assessment taken at baseline
- •- Absolute reticulocyte number >10.000 cells/µL in the last 12 weeks before enrolment and no evidence of loss of efficacy under darbepoetin alfa treatment in patient history
- •- Kt/V = 1.2
- •- Patients >18 years old
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Anti-erythropoietin-antibodies in serum/or and evidence of loss of efficacy under darbepoetin alfa or epoetin alfa treatment in patient history suggesting presence and/or signs of pure red cell aplasia (PCRA)
- •- Severe concomitant chronic disease (e.g., chronic heart failure, New York Heart Association [NYHA] III and IV) or active malignant disease
- •- Life expectancy <2 year
- •- Serum ferritin <100 ng/mL and/or transferrin saturation (TSAT) <20%
- •- Pregnancy or breast feeding
研究者
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