EUCTR2010-020452-64-GB进行中（未招募）1 期
A prospective randomisd open label study to determine the effects of intravenous iron administration on markers of acute kidney injury in chronic kidney disease (CKD) - Effects of intravenous iron therapy on markers of acute kidney injury
Hull and East Yorkshire Hospitals NHS Trust0 个研究点目标入组 100 人开始时间: 2010年10月8日最近更新:
适应症
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
- 100
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
- •Patients with established chronic kidney disease. (Stages III-V) (GFR using MDRD <60ml/min) who are to undergo iron therapy
- •Male, female over 18 years
- •Written and signed informed patient consent
- •No previous iron administration in the last 6 weeks
- •Serum ferritin levels less than 200 mcg/l and/or transferrin saturation <20%
- •Able to meet all study requrements
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Age < 18 years
- •Ferritin greater than 200 mcg/l and Transferrin saturation >40%
- •Known allergy to iron therapy
- •Haemochromatosis
- •Parenteral iron therapy within the previous 6 weeks
- •Inability to co-operate with study protocol
- •Patients with potential confounding factors to NGAL measurement
- •Patients who do not have renal failure (CKD stage I and II)
- •Patients who are unable or do not wish to give consent.
- •Patients being investigated for potential blood loss
- •Patients with a haematological malignancy/ haemolysis
- •Patients with known haemaglobinopathy
- •Patients with a diagnosis of myeloma
- •current smokers
- •Any other contraindications to Monofer, Venofer or Cosmofer therapy listed on SPC
研究者
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