EUCTR2012-003914-15-AT进行中（未招募）1 期
Continuos versus periodic intravenous iron supplementation in maintenance hemodialysis patients
Medizinische Universität Wien, Klinik für Innere Medizin III, Klin. Abteilung für Nephrologie und Dialyse0 个研究点目标入组 140 人开始时间: 2014年5月27日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 140
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
入选标准
- •Patients with anemia and end-stage renal disease on maintenance hemodialysis
- •Hemoglobin = 8,5 g/dl
- •Ferritin < 1000 mg/dl
- •TSAT < 50%
- •CRP < 5 mg/dl
- •Age> 18 years
- •Written informed consent
- •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 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •Hemoglobin < 8,5 g/dl
- •Pregnancy and nursing period
- •Prior allergic reaction on intravenous iron therapy or known allergy on ingredients of the IMP
- •Chronic infectious disease (HIV, Hep B, Hep C)
- •Malignant tumor disease
- •Active infection (CRP > 5 mg/dl, antibiotic treatment – except prophylactic antibiotic treatment)
- •Patients on oral iron therapy at study inclusion
- •Simultaneous participation in another clinical trial
- •Active bleeding
- •Surgical treatment within four weeks prior study inclusion
- •Mental disorder
- •Blood transfusion within four weeks prior study inclusion
- •Drug or alcohol abuse
- •Asthma bronchiale
- •Atopic disease
研究者
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