INFERR - Iron Infusion in Haemodialysis Study: Effect of Intravenous Iron Polymaltose on survival and hospitalisation rates for Indigenous Patients with High Ferritin Levels on Haemodialysis

Menzies School of Health Research0 个研究点目标入组 576 人开始时间: 2020年6月29日最近更新: 2024年9月2日

适应症

试验速览

暂无简介。

•1.Male or female aged less than or equal to 18 years
•2.Identify as Aboriginal and/or Torres Strait Islander
•3.On maintenance haemodialysis for greater than or equal to 3 months
•4.Clinical laboratory results:
•a.haemoglobin less than or equal 115 gram per liter,
•b.ferritin levels greater than or equal to 700 microgram per liter & less than or equal to 2000 microgram per liter
•c.Transferrin Saturation (TSAT) less than 40%
•d.C-reactive protein (CRP) less than 50 milligram per liter
•5.Willing to join the study and can provide informed consent
•6.On adequate Erythropoietin Stimulating Agents (ESA) therapy

•1.History of known allergic or adverse or hypersensitivity reactions to iron polymaltose or parenteral iron products;
•2.Already receiving iron unless they have stopped the iron therapy for greater than or equal to 4 weeks at the time of recruitment;
•3.Has received blood transfusion within the last 4 weeks;
•4.Known iron overload, haemochromatosis, haemoglobinopathy, haemolytic anaemia, aplastic anaemia, lymphoproliferative disease or cancer or on current cancer treatment
•5.Participant’s primary clinician unwilling to enrol
•6.Severe asthma, eczema or allergies;
•7.Not planning to remain resident in the Northern Territory for the next 12 months;
•8.Patients who frequently miss haemodialysis which, in the opinion of the Investigator, would make the participant unsuitable for the study or would prevent compliance with study protocol.
•9.Ferritin greater than 2000 microgram per liter
•10.Tranferrin Saturation (TSAT) greater than or equal to 40%
•11. Life expectancy less than 12 months per the judgement of the investigator
•12.Living-donor transplant scheduled within 12 months
•13. Scheduled to switch to peritoneal dialysis
•Temporary Exclusion Criteria:
•Participant may not enter the trial at any given time if:
•1.Fever greater than 38 degrees Celsius, or has evidence of active bacterial infection, or C-reactive protein (CRP) greater than or equal to 50 milligram per liter

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