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Ultrarapid iron polymaltose infusion for treatment of iron deficiency anaemia in a general hospital population at a single centre safety study

Ultrarapid iron polymaltose infusion for treatment of iron deficiency anaemia in a general hospital population at a single centre safety study

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000272190
Acronym
UltraRIIPH single centre study
Enrollment
300
Registered
2019-02-25
Start date
2019-06-25
Completion date
2021-08-05
Last updated
2023-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Iron deficiency anaemia is a common condition that frequently requires intravenous treatment in patients with chronic conditions. Two formulations of intravenous iron are available in Australia that are used for total body iron replacement. However, the newer ferric carboxymaltose is limited by high cost and a maximum dose of 1000 mg per week over 15 minutes. Iron polymaltose has the advantage of being cost-effective with the ability to provide total body iron replacement in one administration of up to 1500 mg over 1 hour or greater amounts over 4 hours. A pilot study in 2017-2018 demonstrated safety of delivering iron polymaltose at doses up to and including 1500 mg over 30 and 15 minutes. This will be an open-label, single centre study aiming to confirm the safety of iron polymaltose administered as an ultrarapid (15-minute) infusion in a general hospital population. Patients diagnosed with iron deficiency anaemia of any cause requiring replacement with iron polymaltose doses up to 1500 mg will be enrolled into the study after obtaining consent. Rates and severity of adverse events will be compared to those previously published for iron polymaltose administered over 1 hour and 4 hours, as well as to previously published safety outcomes for ferric carboxymaltose infusions.

Interventions

Iron polymaltose at dose of up to and including 1500mg in 250mL of sodium chloride 0.9% infused intravenously over 15 minutes. The doses will be calculated based on patient's weight and haemoglobin level.

Sponsors

Iouri Banakh
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Frankston Hospital patients diagnosed with iron deficiency anaemia of any cause requiring replacement with iron polymaltose doses of up to 1500 mg. Treating team provided consent for their patient to be approached to participate. Patients able to provide informed consent.

Exclusion criteria

Patients requiring doses greater than 1500 mg of iron polymaltose. Patients unable to give informed consent. Patients unable to read English. Treating team declining for their patient to be approached to participate in the study.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026