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

Phase 4

Recruiting

• Conditions: anaemia; high ferritin; low transferrin saturation; Liver disease; Kidney disease; Haemodialysis; Blood - Anaemia; Renal and Urogenital - Kidney disease; Inflammatory and Immune System - Other inflammatory or immune system disorders; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12620000705987
• Lead Sponsor: Menzies School of Health Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-29
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 576

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.Willing to join the study and can provide informed consent
6.On adequate Erythropoietin Stimulating Agents (ESA) therapy

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 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differences according to treatment allocation in risk of hospitalisation with all-cause infection or death.<br>The primary outcome is a composite outcome measure with <br>1.All-cause death<br>2.Hospitalisation with all-cause infection<br><br>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. <br>[ From randomisation up to 48 months]