25,000 Australians have End-stage Kidney Disease (ESKD) and require ongoing dialysis or a kidney transplant. ESKD rates for Indigenous Australians in remote areas are up to 30 times higher than the national average. ESKD impacts Indigenous Australians at a younger age and disproportionately affects women. In the NT, demand for dialysis treatment and the associated expenditure has increased relentlessly over recent decades. There are currently 800 Indigenous Territorians requiring maintenance haemodialysis, representing more than 1 in 50 of the adult population. 120 to 150 new patients start dialysis each year. Admission for dialysis treatment comprises 50% of all NT hospital admissions. Anaemia is a major complication of ESKD and often exacerbated by iron deficiency. It reduces quality of life and is associated with CV events and premature death. EPO is the main agent used to correct anaemia, but requires adequate iron stores to work effectively. Both EPO and IV iron are routine treatment for dialysis patients. Blood tests for ferritin and transferrin saturation are used to guide iron therapy. Ferritin is low with iron deficiency, but it is raised with ongoing inflammation or infection. Indigenous dialysis patients have co existing iron deficiency and recurrent infection. In this setting, there is no evidence to guide the use of IV iron and we do not understand the balance of benefits and harms of this routinely administered treatment. We will conduct a RCT to definitively establish the benefits and harms of IV iron therapy use for Indigenous Australians in the setting of anaemia associated with a heavy burden of recurrent infection. The interventions – IV iron and IV normal saline – are part of usual care. All renal units across the NT have agreed to participate, and we will recruit and randomise 576 patients over 40 months. Follow-up will be undertaken through usual ongoing care. The primary outcome – hospital admission with infection or death – represents a fundamentally important area for clinical research. We need to understanding how to reduce the heavy burden of morbidity and mortality for Indigenous ESKD patients. The research team brings together highly experienced clinician-researchers, statisticians and internationally-recognised kidney disease triallists, and is deeply engaged with Indigenous renal patient advocacy groups and community partnerships across the NT. We are ideally placed to translate results directly into policy and practice through leadership of the NT Renal Clinical Network and being engaged at all levels of renal service delivery. There is a pressing imperative to undertake this RCT to generate evidence to underpin a part of routine care and to ensure we use IV iron appropriately for the benefit of Indigenous dialysis patients.

https://hdl.handle.net/10137/12764

Anaemia/Liver Disease/Kidney Disease

Iron infusion in Haemodialysis Study: Intravenous Iron Polymaltose For Indigenous Patients with High Ferritin Levels on Haemodialysis: A Prospective Open-Label Blinded Endpoint Randomised Controlled Trial

Interventional/Clinical trials research

Project