학술논문
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
Document Type
article
Author
Sandawana William Majoni; Jane Nelson; Darren Germaine; Libby Hoppo; Stephanie Long; Shilpa Divakaran; Brandon Turner; Jessica Graham; Sajiv Cherian; Basant Pawar; Geetha Rathnayake; Bianca Heron; Louise Maple-Brown; Robert Batey; Peter Morris; Jane Davies; David ( Kiran) Fernandes; Madhivanan Sundaram; Asanga Abeyaratne; Yun Hui Sheryl Wong; Paul D. Lawton; Sean Taylor; Federica Barzi; Alan Cass; for the INFERR study Group
Source
Trials, Vol 22, Iss 1, Pp 1-21 (2021)
Subject
Language
English
ISSN
1745-6215
Abstract
Abstract 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 (