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Trial registered on ANZCTR


Registration number
ACTRN12619000272190
Ethics application status
Approved
Date submitted
14/02/2019
Date registered
25/02/2019
Date last updated
5/11/2021
Date data sharing statement initially provided
25/02/2019
Date results information initially provided
5/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Ultrarapid iron polymaltose infusion for treatment of iron deficiency anaemia in a general hospital population at a single centre safety study
Scientific title
Ultrarapid iron polymaltose infusion for treatment of iron deficiency anaemia in a general hospital population at a single centre safety study
Secondary ID [1] 297402 0
Nil known
Universal Trial Number (UTN)
Trial acronym
UltraRIIPH single centre study
Linked study record
ACTRN12617001615370 was a pilot study and the current study is a follow up full version of that study.

Health condition
Health condition(s) or problem(s) studied:
Iron deficiency 311561 0
Iron deficiency anaemia 311562 0
Anaemia of chronic kidney disease 311563 0
Anaemia of chronic heart failure 311564 0
Condition category
Condition code
Blood 310195 310195 0 0
Anaemia
Cardiovascular 310249 310249 0 0
Other cardiovascular diseases
Renal and Urogenital 310267 310267 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 313653 0
Treatment: Drugs
Comparator / control treatment
The safety results will be compared to previously published rates of adverse effects of iron polymaltose infused over 1 hour and over 4 hours, as well as to that of ferric carboxymaltose. The controls were obtained from 2015-2016 Victoria, Australia for iron polymaltose infusions. The control data for ferric carboxymaltose is sourced from multiple studies from different countries and published as systematic reviews from data over the last decade.
Control group
Historical

Outcomes
Primary outcome [1] 319082 0
The primary outcome is the overall adverse event rate during the iron polymaltose infusions. Nursing staff will assess for any adverse events and these will be classified as mild reactions which are defined as those that do not require a change in the infusion rate, treatment or prolongation of hospital stay; moderate reactions are defined as those that require an interruption or change to infusion rate, minor treatment such as analgesia or additional monitoring; and severe reactions are defined as those that require the iron infusion to be stopped without intention to restart and where patients require urgent medical attention with administration of resuscitation or severe allergic reaction medications such as adrenaline, hydrocortisone or parenteral antihistamine, or prolongation of hospitalisation (more than 1 day). Examples of reactions include arm pain, chest pain, anaphylaxis, palpitations or unusual sensation in arms.
Timepoint [1] 319082 0
Adverse events occurring during the 15 minute infusions.
Secondary outcome [1] 366935 0
Secondary outcomes include the adverse event rate during the week post-infusion as well as severity of adverse events, graded as mild, moderate or severe. During the week post infusion, adverse events will be graded as: mild for those not requiring treatment; moderate where minor treatment was required; and severe for those requiring attention of a local doctor or hospital presentation. These will be obtained by directly contacting patients via phone on week after the infusion for selfreporting of any reactions. Examples of reactions include: headache, arthralgia, myalgia, fatigue, dizziness and nausea.
Timepoint [1] 366935 0
Within 1 week of the iron infusion.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety
Statistical methods / analysis
Based on previous study results of sufficiently powered studies, an overall adverse event rate of 8-9% is expected, with an acceptable safety rate of up to 4% for severe adverse events as was used by the original rapid infusion study conducted in Victoria (including Peninsula Health) in 2009. Calculated participant number of 172 patients will be required to power the study to 80% with a 2-sided alpha of 0.05 to detect a 3% increase in severe reactions, and 249 participants will be required to detect a 7% increase in overall adverse effects. The original rapid infusion study of 100 participants had a rate of any adverse events of 24%, which was considered acceptable for inclusion into hospital guidelines for clinical use. A total of 300 participants will targeted for enrolment into this study, to allow for 10-20% drop out rate or loss to follow up for 1 week adverse effect data collection. Adverse event rates will be compared using Fisher's exact test and Mann-Witney U test, and baseline parameters using Fisher's exact and student-t test or Mann-Witney U test if non-normally distributed data is identified.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 25678 0
3199 - Frankston

Funding & Sponsors
Funding source category [1] 301973 0
Self funded/Unfunded
Name [1] 301973 0
Iouri Banakh
Address [1] 301973 0
Pharmacy Department, Frankston Hospital
2 Hastings Road,
Frankston Victoria 3199
Country [1] 301973 0
Australia
Primary sponsor type
Individual
Name
Iouri Banakh
Address
Pharmacy Department, Frankston Hospital
2 Hastings Road,
Frankston Victoria 3199
Country
Australia
Secondary sponsor category [1] 301748 0
None
Name [1] 301748 0
Address [1] 301748 0
Country [1] 301748 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302653 0
Peninsula Health Human Research and Ethic Committee
Ethics committee address [1] 302653 0
2 Hastings Road,
Frankston Victoria 3199
Ethics committee country [1] 302653 0
Australia
Date submitted for ethics approval [1] 302653 0
20/03/2019
Approval date [1] 302653 0
18/06/2019
Ethics approval number [1] 302653 0
HREC/50300/PH-2019

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90942 0
Mr Iouri Banakh
Address 90942 0
Pharmacy Department, Frankston Hospital
2 Hasting Road,
Frankston Victoria 3199
Country 90942 0
Australia
Phone 90942 0
+61397847602
Fax 90942 0
+61397842335
Email 90942 0
ibanakh@phcn.vic.gov.au
Contact person for public queries
Name 90943 0
Mr Iouri Banakh
Address 90943 0
Pharmacy Department, Frankston Hospital
2 Hasting Road,
Frankston Victoria 3199
Country 90943 0
Australia
Phone 90943 0
+61397847602
Fax 90943 0
+61397842335
Email 90943 0
ibanakh@phcn.vic.gov.au
Contact person for scientific queries
Name 90944 0
Mr Iouri Banakh
Address 90944 0
Pharmacy Department, Frankston Hospital
2 Hasting Road,
Frankston Victoria 3199
Country 90944 0
Australia
Phone 90944 0
+61397847602
Fax 90944 0
+61397842335
Email 90944 0
ibanakh@phcn.vic.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not part of the protocol.
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 1352 0
Study protocol
Citation [1] 1352 0
Link [1] 1352 0
Email [1] 1352 0
Other [1] 1352 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary
Ultrarapid iron polymaltose infusions have similar safety to 1 hour and 4 hours infusions, and that of ferric carboxymaltose. The delayed reaction rate was 12..5% with mostly mild side effects reported by study participants. Over 95% of participants indicated that they would have iron polymaltose infusions at the ultrarapid rates again if offered for their treatment.