RecruitingPhase 4ACTRN12620000705987

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

Sponsor

Menzies School of Health Research

Enrollment

576 participants

Start Date

Dec 8, 2020

Study Type

Interventional

Conditions

high ferritin low transferrin saturation Haemodialysis

Summary

The Iron Infusion in Haemodialysis Study – Intravenous iron polymaltose versus no iron in maintenance haemodialysis (MHD): a prospective open-label blinded endpoint randomised controlled trial – will assess the safety and effectiveness of intravenous iron treatment among Indigenous MHD patients with anaemia, high ferritin and low transferrin saturation. All patients 18 years or older on MHD for greater than or equal to 3 months will be eligible for screening and recruitment. We will randomise 576 patients across the Northern Territoy to achieve study power of greater than 80% in detecting a 30% reduction in time to the first of hospitalisation with infection or death. Secondary outcomes will be all serious adverse events, hospital admissions, infection rates, differences in haemoglobin levels over 6 to 12 months, and death. A cost analysis will be performed looking at the costs of treatment, hospital admissions and procedures between the intervention arm versus the control.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Many Aboriginal and Torres Strait Islander people in the Northern Territory require ongoing kidney dialysis (haemodialysis) due to advanced kidney disease. Anaemia — low red blood cell levels — is common in dialysis patients and is usually treated with iron. However, some patients on dialysis develop unusual blood results: they have high ferritin (a marker often used to estimate iron stores) yet their bodies still struggle to use available iron for making red blood cells. The INFERR study is testing whether giving intravenous iron to these specific patients — those with high ferritin, low transferrin saturation, and anaemia — can safely reduce the risk of hospitalisation and death. This is an important question because current clinical guidelines are inconsistent about whether to give or withhold iron in this situation. You may be eligible if you are 18 or older, identify as Aboriginal and/or Torres Strait Islander, have been on maintenance haemodialysis for at least three months in the Northern Territory, have anaemia with high ferritin (700–2000 mcg/L) and low transferrin saturation, and plan to remain in the NT for the next 12 months. People with known allergies to iron products or active infections at the time of enrolment are not eligible.

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Interventions

Intervention Treatment Group (Arm A): 400 mg of Iron Polymaltose administered intravenously by the dialysis nurse at the renal unit divided equally (200 mg) over two haemodialysis sessions monthly for up to 48 months Adherence to the treatment will be monitored by attendance for haemodialysis as the treatment is routinely given by the nurses during dialysis. The rates of non-adherence are anticipated to be very low because for this reason.