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: 2020年7月27日

适应症

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•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

•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

发起方

Hull and East Yorkshire Hospitals NHS Trust