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

Trials

Peter Morris¹  Jane Davies²  Basant Pawar³  David ( Kiran) Fernandes³  Robert Batey⁴  Madhivanan Sundaram⁵  Bianca Heron⁵  Brandon Turner⁶  Darren Germaine⁶  Jessica Graham⁶  Alan Cass⁶  Libby Hoppo⁶  Jane Nelson⁶  Stephanie Long⁶  Louise Maple-Brown⁷  Yun Hui Sheryl Wong⁸  Shilpa Divakaran⁸  Sean Taylor⁸  Sandawana William Majoni⁹  Asanga Abeyaratne⁹  Sajiv Cherian^1,10  Paul D. Lawton^1,11  Federica Barzi^1,12  Geetha Rathnayake^1,13 

[1] Child Health Division, Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia;Department of Pediatrics, Division of Women, Children and Youth, Royal Darwin Hospital, Darwin, Northern Territory, Australia;Department of Infectious Diseases, Division of Medicine, Royal Darwin Hospital, Darwin, Northern Territory, Australia;Global and Tropical Health Division, Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia;Department of Nephrology, Division of Medicine, Alice Springs Hospital, Alice Springs, Northern Territory, Australia;Department of Nephrology, Division of Medicine, Alice Springs Hospital, Alice Springs, Northern Territory, Australia;New South Wales Health, St Leonards, NSW, Australia;Department of Nephrology, Division of Medicine, Royal Darwin Hospital, P.O. Box 41326, Casuarina, Darwin, Northern Territory, Australia;Division of Wellbeing and Preventable Chronic Diseases, Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia;Division of Wellbeing and Preventable Chronic Diseases, Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia;Department of Endocrinology, Division of Medicine, Royal Darwin Hospital, Darwin, Northern Territory, Australia;Division of Wellbeing and Preventable Chronic Diseases, Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia;Department of Nephrology, Division of Medicine, Royal Darwin Hospital, P.O. Box 41326, Casuarina, Darwin, Northern Territory, Australia;Division of Wellbeing and Preventable Chronic Diseases, Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia;Department of Nephrology, Division of Medicine, Royal Darwin Hospital, P.O. Box 41326, Casuarina, Darwin, Northern Territory, Australia;Flinders University and Northern Territory Medical Program, Royal Darwin Hospital Campus, Darwin, Northern Territory, Australia;Division of Wellbeing and Preventable Chronic Diseases, Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia;Flinders University and Northern Territory Medical Program, Royal Darwin Hospital Campus, Darwin, Northern Territory, Australia;Department of Nephrology, Division of Medicine, Alice Springs Hospital, Alice Springs, Northern Territory, Australia;Division of Wellbeing and Preventable Chronic Diseases, Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia;The Central Clinical School, Monash University & Alfred Health, Melbourne, Australia;Division of Wellbeing and Preventable Chronic Diseases, Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia;UQ Poche Centre for Indigenous Health, The University of Queensland, 4067, St Lucia, Queensland, Australia;Flinders University and Northern Territory Medical Program, Royal Darwin Hospital Campus, Darwin, Northern Territory, Australia;Chemical Pathology–Territory Pathology, Department of Health, Northern Territory Government, Darwin, Northern Territory, Australia;

关键词: Aboriginal and Torres Strait Islander Australians;    First Nations Australians;    Anaemia;    Chronic kidney disease;    Maintenance haemodialysis;    Ferritin;    Iron deficiency;    Intravenous iron;   

DOI  :  10.1186/s13063-021-05854-w

来源: Springer

【 摘 要 】

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 saturationMethodsIn 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.DiscussionThe 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.

【 授权许可】

CC BY