Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001273370
Ethics application status
Approved
Date submitted
21/08/2017
Date registered
4/09/2017
Date last updated
26/08/2019
Date data sharing statement initially provided
26/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Rapid Iron Infusion Study- a randomised controlled trial (RCT) of the treatment of iron deficiency anaemia in children (RIIS)
Scientific title
Rapid ferric carboxymaltose infusion (Ferinject) for Iron Deficiency Anaemia in Aboriginal children: a randomised controlled trial
Secondary ID [1] 292032 0
Nil Known
Universal Trial Number (UTN)
Not available
Trial acronym
RIIS
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Childhood Iron Deficiency Anaemia 303424 0
Condition category
Condition code
Blood 302837 302837 0 0
Anaemia
Diet and Nutrition 302838 302838 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single Ferric carboxymaltose infusion (Ferinject) 20mg/kg over 15 minutes in normal saline solution administered prior to discharge from hospital
Intervention code [1] 298161 0
Treatment: Drugs
Comparator / control treatment
Intramuscular iron injection with dose calculated according to weight and haemoglobin level as per Clinic Manual for Primary Health Care Practitioners in Remote and Indigenous Health Services in Central and Northern Australia (CARPA Standard Treatment Manual).
Control group
Active

Outcomes
Primary outcome [1] 302230 0
Haemoglobin level
Timepoint [1] 302230 0
At the time of anaemia requiring additional iron treatment or at the final assessment at 6-9 months post randomisation (whichever is first).

Secondary outcome [1] 335252 0
Clinical treatment failure
Timepoint [1] 335252 0
Clinical treatment failure as defined by either anaemia requiring additional treatment or haemoglobin <110g/L at the final assessment at 6-9 months post randomisation
Secondary outcome [2] 335253 0
Proportion of adverse drug reactions (urticaria, headache, nausea, vomiting etc) and serious adverse events (anaphylaxis)
Timepoint [2] 335253 0
Study outcome will be gathered from remote communities within 6-9 months post randomisation
Secondary outcome [3] 336937 0
Data will be collected for the number of sick visits and well visits with reasons for attendance (primary and secondary diagnoses) in the clinic. The illnesses documented in the clinical record and any admissions to hospital will also be checked.
Timepoint [3] 336937 0
within 6-9 months post randomisation
Secondary outcome [4] 336938 0
Rates of attendance at the local health centre
Timepoint [4] 336938 0
within 6-9 months post randomisation

Eligibility
Key inclusion criteria
Aboriginal or Torres Strait Islander children with Iron deficiency anaemia (a haemoglobin level (Hb) <110g/L and mean cell volume (MCV) <75fL), will be eligible to participate in the randomised trial if the treating clinician recommends parenteral iron treatment.
Minimum age
No limit
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) parenteral iron treatment or blood transfusion within the last 4 weeks; 2) known iron overload, haemoglobinopathy, haemolytic anaemia, aplastic anaemia, lymphoproliferative disease or current cancer treatment; 3) febrile >38 degree centigrade or very unwell or receiving phosphate supplementation at the time of discharge; 4) lack of access to a primary health provider in the NT; 5) allergy or hypersensitivity to Ferinject or any of its excipients; 6) known serious hypersensitivity to other parenteral iron products; 7) severe asthma, eczema or allergies; 8) not planning to remain resident in the NT for 12 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will involve contacting the NHMRC Clinical Trials Centre Randomisation Service in Sydney.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation will be by the independent NHMRC Clinical Trial Centre Randomisation service using a comuterised random allocation system that takes into account age (<2 years; 2-5 years) and Haemoglobin (<90 g/L; 90-110 g/L)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The primary analysis will report the mean difference and 95% confidence interval in change in haemoglobin level between the 2 groups (as allocated, irrespective of actual treatment received). Differences in haemoglobin level (a normally distributed continuous outcome) will be assessed using analysis of covariance (ANCOVA) with adjustment for baseline Haemoglobin level.

Secondary outcomes: The difference between the groups will be assessed using Fisher’s Exact test for binary outcomes (clinical failure, serious adverse events), Kaplan-Meier curves with log rank statistic for time to event (time to clinical treatment failure).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/09/2017
Actual
13/09/2017
Date of last participant enrolment
Anticipated
31/12/2019
Actual
Date of last data collection
Anticipated
30/06/2020
Actual
Sample size
Target
226
Accrual to date
130
Final
Recruitment in Australia
Recruitment state(s)
NT
Recruitment hospital [1] 8202 0
Royal Darwin Hospital - Tiwi
Recruitment hospital [2] 14647 0
Katherine Hospital - Katherine
Recruitment postcode(s) [1] 16261 0
0810 - Tiwi
Recruitment postcode(s) [2] 27671 0
0850 - Katherine

Funding & Sponsors
Funding source category [1] 296564 0
Government body
Name [1] 296564 0
NHMRC
Country [1] 296564 0
Australia
Primary sponsor type
Other
Name
Menzies School of Health Research
Address
PO Box 41096, Casuarina NT 0811, Australia
Office: John Mathews Building (Building 58), Royal Darwin Hospital Campus, Rocklands Drive, Casuarina NT 0810
Country
Australia
Secondary sponsor category [1] 295560 0
None
Name [1] 295560 0
Address [1] 295560 0
Country [1] 295560 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297780 0
Human Research Ethics of the Northern Territory
Ethics committee address [1] 297780 0
Ethics committee country [1] 297780 0
Australia
Date submitted for ethics approval [1] 297780 0
29/03/2017
Approval date [1] 297780 0
24/04/2017
Ethics approval number [1] 297780 0
HREC 2017-2812

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75090 0
Prof Peter Morris
Address 75090 0
Menzies- School of Health Research
John Mathews Building (JMB)
Building 58, Royal Darwin Hospital Campus
John Mathews Building (Bldg 58), Royal Darwin Hospital Campus, Rocklands Drive, Tiwi NT 0810
Country 75090 0
Australia
Phone 75090 0
+618 8946 8594
Fax 75090 0
Email 75090 0
peter.morris@menzies.edu.au
Contact person for public queries
Name 75091 0
Jennifer Wong
Address 75091 0
Menzies- School of Health Research
John Mathews Building (JMB)
Building 58, Royal Darwin Hospital Campus
John Mathews Building (Bldg 58), Royal Darwin Hospital Campus, Rocklands Drive, Tiwi NT 0810
Country 75091 0
Australia
Phone 75091 0
+618 8946 8594
Fax 75091 0
Email 75091 0
jennifer.wong@menzies.edu.au
Contact person for scientific queries
Name 75092 0
Peter Morris
Address 75092 0
Menzies- School of Health Research
John Mathews Building (JMB)
Building 58, Royal Darwin Hospital Campus
John Mathews Building (Bldg 58), Royal Darwin Hospital Campus, Rocklands Drive, Tiwi NT 0810
Country 75092 0
Australia
Phone 75092 0
+618 8946 8594
Fax 75092 0
Email 75092 0
peter.morris@menzies.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
please contact research team


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.