INFERR-Iron Infusion in Haemodialysis Primary Data
Menzies School of Health ResearchDataset description
End-stage kidney disease (ESKD) rates for Aboriginal and Torres Strait Islander people in remote areas are up to 30 times higher than the national average. Anaemia is a major complication of ESKD and often exacerbated by iron deficiency. It reduces quality of life and is associated with cardiovascular (CV) events and premature death. Erythropoietin (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. Aboriginal and Torres Strait Islander dialysis patients have co-existing iron deficiency, high ferritin and ongoing inflammation. 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. The primary outcome is a composite outcome measure with: 1. All-cause death 2. Hospitalisation with a principal diagnosis of all-cause infection Data Description • Hospitalisations • Pathology Results • Comorbidities/Medical History • Prescribed medicationsIdentifiers
Source Study
Trial acronym
INFERR
Trial ID
ACTRN12620000705987
Purpose
Treatment
Phase
Phase 4
Funding
Government body,National Health and Medical Research Council
Scientific enquiries
A/Prof Sandawana William Majoni
Brief 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 57 .... Read more
Key Inclusion Criteria
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. Willin .... Read more
Key Exclusion Criteria
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 prim .... Read more
Can healthy volunteers participate?
No
Population
Sample Size 576
Min. age 18 Years
Max. age No limit
Sex Both males and females
Condition category Haemodialysis , Kidney disease , Liver disease , anaemia , high ferritin , low transferrin saturation
Condition code Blood , Inflammatory and Immune System , Oral and Gastrointestinal , Renal and Urogenital
Intervention
Intervention code Treatment: Drugs
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.
Comparison
Control group Active
Control Treatment Group (Arm B): No iron treatment will be administered
Outcomes
Outcome: Differences according to treatment allocation in risk of hospitalisation with all-cause infection or death. The primary outcome is a composite outcome measure with 1. All-cause death 2. Hospitalisation with all-cause infection Outcome data will be collected from patient medical records. The data will also be entered into the CRFs during each follow up visit. Blinded outcomes adjudication will be performed by adjudicators independent of the study. Timepoint: From .... Read more
Will individual participant data (IPD) for this trial be available?
No