Evidence map›Paper›PMID 34857020›Full record

ArticleTrials2021

INFERR-Iron infusion in haemodialysis study: INtravenous iron polymaltose for First Nations Australian patients with high FERRitin levels on haemodialysis-a protocol for a prospective open-label blinded endpoint randomised controlled trial.

Sandawana William Majoni, Jane Nelson, Darren Germaine, Libby Hoppo, Stephanie Long, Shilpa Divakaran, Brandon Turner, Jessica Graham, Sajiv Cherian, Basant Pawar and 15 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
2.5field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 18 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors at 6 institutions in 1 country.

Sandawana William MajoniDivision of Wellbeing and Preventable Chronic Diseases, Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia. sandawanaw@aol.com.ORCID http://orcid.org/0000-0003-0039-1913
Jane NelsonDivision of Wellbeing and Preventable Chronic Diseases, Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.
Darren GermaineDivision of Wellbeing and Preventable Chronic Diseases, Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.
Libby HoppoDivision of Wellbeing and Preventable Chronic Diseases, Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.
Stephanie LongDivision of Wellbeing and Preventable Chronic Diseases, Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.
Shilpa DivakaranDivision of Wellbeing and Preventable Chronic Diseases, Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.
Brandon TurnerDivision of Wellbeing and Preventable Chronic Diseases, Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.
Jessica GrahamDivision of Wellbeing and Preventable Chronic Diseases, Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.
Sajiv CherianDivision of Wellbeing and Preventable Chronic Diseases, Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.
Basant PawarDepartment of Nephrology, Division of Medicine, Alice Springs Hospital, Alice Springs, Northern Territory, Australia.
Geetha RathnayakeFlinders University and Northern Territory Medical Program, Royal Darwin Hospital Campus, Darwin, Northern Territory, Australia.
Bianca HeronDepartment of Nephrology, Division of Medicine, Royal Darwin Hospital, P.O. Box 41326, Casuarina, Darwin, Northern Territory, Australia.
Louise Maple-BrownDivision of Wellbeing and Preventable Chronic Diseases, Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.
Robert BateyDepartment of Nephrology, Division of Medicine, Alice Springs Hospital, Alice Springs, Northern Territory, Australia.
Peter MorrisChild Health Division, Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.
Jane DaviesDepartment of Infectious Diseases, Division of Medicine, Royal Darwin Hospital, Darwin, Northern Territory, Australia.
David Kiran FernandesDepartment of Nephrology, Division of Medicine, Alice Springs Hospital, Alice Springs, Northern Territory, Australia.
Madhivanan SundaramDepartment of Nephrology, Division of Medicine, Royal Darwin Hospital, P.O. Box 41326, Casuarina, Darwin, Northern Territory, Australia.
Asanga AbeyaratneDivision of Wellbeing and Preventable Chronic Diseases, Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.
Yun Hui Sheryl WongDivision of Wellbeing and Preventable Chronic Diseases, Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.
Paul D LawtonDivision of Wellbeing and Preventable Chronic Diseases, Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.
Sean TaylorDivision of Wellbeing and Preventable Chronic Diseases, Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.
Federica BarziDivision of Wellbeing and Preventable Chronic Diseases, Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.
Alan CassDivision of Wellbeing and Preventable Chronic Diseases, Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.
INFERR study Group
Charles Darwin University · AUAlice Springs Hospital · AURoyal Darwin Hospital · AUGovernment of the Northern Territory · AUNew South Wales Department of Health · AUThe University of Queensland · AU

Funding

National Health and Medical Research Council GRANT1163841
6 · The paper itself

Abstract

backgroundThe effectiveness of erythropoiesis-stimulating agents, which are the main stay of managing anaemia of chronic kidney disease (CKD), is largely dependent on adequate body iron stores. The iron stores are determined by the levels of serum ferritin concentration and transferrin saturation. These two surrogate markers of iron stores are used to guide iron replacement therapy. Most Aboriginal and/or Torres Islander Australians of the Northern Territory (herein respectfully referred to as First Nations Australians) with end-stage kidney disease have ferritin levels higher than current guideline recommendations for iron therapy. There is no clear evidence to guide safe and effective treatment with iron in these patients. We aim to assess the impact of intravenous iron treatment on all-cause death and hospitalisation with a principal diagnosis of all-cause infection in First Nations patients on haemodialysis with anaemia, high ferritin levels and low transferrin saturation

methodsIn a prospective open-label blinded endpoint randomised controlled trial, a total of 576 participants on maintenance haemodialysis with high ferritin (> 700 μg/L and ≤ 2000 μg/L) and low transferrin saturation (< 40%) from all the 7 renal units across the Northern Territory of Australia will be randomised 1:1 to receive intravenous iron polymaltose 400 mg once monthly (200 mg during 2 consecutive haemodialysis sessions) (Arm A) or no IV iron treatment (standard treatment) (Arm B). Rescue therapy will be administered when the ferritin levels fall below 700 μg/L or when clinically indicated. The primary outcome will be the differences between the two study arms in the risk of hospitalisation with all-cause infection or death. An economic analysis and several secondary and tertiary outcomes analyses will also be performed. DISCUSSION: The INFERR clinical trial will address significant uncertainty on the safety and efficacy of iron therapy in First Nations Australians with CKD with hyperferritinaemia and evidence of iron deficiency. This will hopefully lead to the development of evidence-based guidelines. It will also provide the opportunity to explore the causes of hyperferritinaemia in First Nations Australians from the Northern Territory.

trial registrationThis trial is registered with The Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12620000705987 . Registered 29 June 2020.

Indexed as

Indigenous PeoplesIron DeficienciesAustraliaAustralian Aboriginal and Torres Strait Islander PeoplesFerric CompoundsFerritinsHumansIronProspective StudiesRandomized Controlled Trials as TopicRenal DialysisFerric CompoundsFerritinsIronteferrolAboriginal and Torres Strait Islander AustraliansAnaemiaChronic kidney diseaseFerritinFirst Nations AustraliansIntravenous ironIron deficiencyMaintenance haemodialysis

Identifiers

PMID34857020
PMCPMC8641231
OpenAlexW3211089393

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.