跳至主要内容
临床试验/EUCTR2006-005916-29-DE
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

发起方
Westpfalz-Klinikum GmbH

相似试验