None listed
Conditions
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 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.
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.
Sponsors
Menzies School of Health Research
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed