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.

• Published in: Trials
• Main Authors: Majoni SW, Nelson J, Germaine D, Hoppo L, Long S, Divakaran S, Turner B, Graham J, Cherian S, Pawar B, Rathnayake G, Heron B, Maple-Brown LJ, Batey R, Morris P, Davies J, Fernandes DK, Sundaram M, Abeyaratne A, Wong YHS, Lawton PD, Taylor Sean, Barzi F, Cass A
• Format: Article in Journal/Newspaper
• Language: English
• Published: 2021
• Subjects: *Anemia; Iron-Deficiency/diagnosis/drug therapy; Australia; Ferric Compounds; Ferritins; Humans; Iron; *Iron Deficiencies; Prospective Studies; Randomized Controlled Trials as Topic; Renal Dialysis/adverse effects; First Nations
• Online Access: https://hdl.handle.net/10137/11974; https://doi.org/10.1186/s13063-021-05854-w; https://www.ezpdhcs.nt.gov.au/login?url=https://www.ncbi.nlm.nih.gov/pubmed/34857020

BACKGROUND: The 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 METHODS: In 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 ...