Continuous Versus Periodic Intravenous Iron Supplementation in Maintenance Hemodialysis Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 2
- 主要终点
- Serum hemoglobin level (g/dl)
研究概览
简要总结
Patients with end-stage kidney disease on maintenance hemodialysis frequently require iron supplementation to compensate for ongoing iron losses, and to maintain hemoglobin levels with or without additional use of erythropoiesis-stimulating agents (ESA).
The investigators aim to compare two different intravenous iron preparations, ferric carboxymaltose and iron sucrose in 140 hemodialysis patients. The investigators primary objective is to assess whether both agents are equally effective to maintain a target haemoglobin within 10-12 mg/dl. The investigators will also measure ferritin, transferrin, transferrin saturation, and how much ESA therapy is administered.
Patients will be randomly assigned to either treatment group and followed in parallel over an active study period of 40 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Signed informed consent
- •Male and female patients aged ≥ 18
- •Patients with anemia and end stage kidney disease on dialysis
- •Hemoglobin ≥ 8,5g/dl
- •Ferritin < 1000mg/dl
- •TSAT < 50%
- •CRP < 5mg/dl
排除标准
- •Hemoglobin < 8,5g/dl
- •Pregnancy or Nursing
- •Known allergic reaction to i.v. iron supplementation or to ingredients of Investigational Medicinal Product (IMP)
- •Chronic infections (HIV, Hep B, Hep C)
- •Acute infections (CRP>5mg/dl; Antibiotic therapy except for prophylactic use)
- •Malignant tumor disease
- •Oral iron supplementation at study inclusion
- •Participation in a different study at the same time
- •Active bleeding issues
- •Surgical intervention within the last 4 weeks before study inclusion
- •Mental diseases
- •Bronchial asthma
- •Atopic allergy
- •Receipt of red blood cell (RBC) concentrate within the last 4 weeks before study inclusion
研究组 & 干预措施
Iron sucrose
Supplementation of iron sucrose 100 mg at week 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38
干预措施: Supplementation of iron sucrose (Drug)
Ferric carboxymaltose
Supplementation of ferric carboxymaltose 500 mg at week 0, 10, 20, 30
干预措施: Supplementation of ferric carboxymaltose (Drug)
结局指标
主要结局
Serum hemoglobin level (g/dl)
时间窗: 40 weeks
次要结局
- Serum ferritin level (µg/l)(Week 0, 10, 20, 30, 40)
- Serum transferrin level (mg/dl)(Week 0, 10, 20, 30, 40)
- Serum level of transferrin saturation (TSAT) (%)(Week 0, 10, 20, 30, 40)
- ESA consumption in I.E./week or µg/week as appropriate(Week 0, 10, 20, 30, 40)
研究者
Gere Sunder-Plassmann
Prof. Dr.
Medical University of Vienna