EUCTR2006-005916-29-DE进行中(未招募)不适用
IFEROS – Influence of intravenous iron therapeutics on oxidative stress in hemodialysis patients - IFEROS
Westpfalz-Klinikum GmbH0 个研究点开始时间: 2007年6月5日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
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
- •stable hemodialysis patients at least three months on HD
- •age > 18 years
- •adequate hemodialysis with kt/v > 1,3
- •adequate iron stores with Serum-Ferritin >100 µg/dl and TSAT >20% or hypochrome erythrocytes < 10%
- •CRP < 30 mg/l
- •Hemoglobin >10 g/dl
- •stable on erythropoeitin: erythropoetin-dose 50 – 150 IU/kg/Woche and no change of erythropoeitin-dose > 30% in the last 8 weeks
- •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
- •·clinical signs of relevant inflammation or CRP > 30 mg/l
- •Hemoglobin < 10 g/dl or Hemoglobin >13g/dl
- •Serum-Ferritin <100 µg/dl or Serum-Ferritin > 800 µg/dl
- •TSAT > 50%
- •weekly iron substitition > 100 mg
- •hematologic systemic disease
- •immunsuppressive or cytostatic therapy
- •therapy with vitamin C, vitamin E or Acetylcystein
研究者
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