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
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 sat...
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Springer Science and Business Media LLC
2021
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Online Access: | http://dx.doi.org/10.1186/s13063-021-05854-w https://link.springer.com/content/pdf/10.1186/s13063-021-05854-w.pdf https://link.springer.com/article/10.1186/s13063-021-05854-w/fulltext.html |
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crspringernat:10.1186/s13063-021-05854-w 2023-05-15T16:15:20+02:00 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 Majoni, Sandawana William Nelson, Jane Germaine, Darren Hoppo, Libby Long, Stephanie Divakaran, Shilpa Turner, Brandon Graham, Jessica Cherian, Sajiv Pawar, Basant Rathnayake, Geetha Heron, Bianca Maple-Brown, Louise Batey, Robert Morris, Peter Davies, Jane Fernandes, David Sundaram, Madhivanan Abeyaratne, Asanga Wong, Yun Hui Sheryl Lawton, Paul D. Taylor, Sean Barzi, Federica Cass, Alan National Health and Medical Research Council 2021 http://dx.doi.org/10.1186/s13063-021-05854-w https://link.springer.com/content/pdf/10.1186/s13063-021-05854-w.pdf https://link.springer.com/article/10.1186/s13063-021-05854-w/fulltext.html en eng Springer Science and Business Media LLC https://creativecommons.org/licenses/by/4.0 https://creativecommons.org/licenses/by/4.0 CC-BY Trials volume 22, issue 1 ISSN 1745-6215 Pharmacology (medical) Medicine (miscellaneous) journal-article 2021 crspringernat https://doi.org/10.1186/s13063-021-05854-w 2022-01-04T16:41:01Z 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 (< 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 registration This trial is registered with The Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12620000705987. Registered 29 June 2020. Article in Journal/Newspaper First Nations Springer Nature (via Crossref) New Zealand Trials 22 1 |
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Springer Nature (via Crossref) |
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English |
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Pharmacology (medical) Medicine (miscellaneous) |
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Pharmacology (medical) Medicine (miscellaneous) Majoni, Sandawana William Nelson, Jane Germaine, Darren Hoppo, Libby Long, Stephanie Divakaran, Shilpa Turner, Brandon Graham, Jessica Cherian, Sajiv Pawar, Basant Rathnayake, Geetha Heron, Bianca Maple-Brown, Louise Batey, Robert Morris, Peter Davies, Jane Fernandes, David Sundaram, Madhivanan Abeyaratne, Asanga Wong, Yun Hui Sheryl Lawton, Paul D. Taylor, Sean Barzi, Federica Cass, Alan 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 |
topic_facet |
Pharmacology (medical) Medicine (miscellaneous) |
description |
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 (< 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 registration This trial is registered with The Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12620000705987. Registered 29 June 2020. |
author2 |
National Health and Medical Research Council |
format |
Article in Journal/Newspaper |
author |
Majoni, Sandawana William Nelson, Jane Germaine, Darren Hoppo, Libby Long, Stephanie Divakaran, Shilpa Turner, Brandon Graham, Jessica Cherian, Sajiv Pawar, Basant Rathnayake, Geetha Heron, Bianca Maple-Brown, Louise Batey, Robert Morris, Peter Davies, Jane Fernandes, David Sundaram, Madhivanan Abeyaratne, Asanga Wong, Yun Hui Sheryl Lawton, Paul D. Taylor, Sean Barzi, Federica Cass, Alan |
author_facet |
Majoni, Sandawana William Nelson, Jane Germaine, Darren Hoppo, Libby Long, Stephanie Divakaran, Shilpa Turner, Brandon Graham, Jessica Cherian, Sajiv Pawar, Basant Rathnayake, Geetha Heron, Bianca Maple-Brown, Louise Batey, Robert Morris, Peter Davies, Jane Fernandes, David Sundaram, Madhivanan Abeyaratne, Asanga Wong, Yun Hui Sheryl Lawton, Paul D. Taylor, Sean Barzi, Federica Cass, Alan |
author_sort |
Majoni, Sandawana William |
title |
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 |
title_short |
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 |
title_full |
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 |
title_fullStr |
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 |
title_full_unstemmed |
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 |
title_sort |
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 |
publisher |
Springer Science and Business Media LLC |
publishDate |
2021 |
url |
http://dx.doi.org/10.1186/s13063-021-05854-w https://link.springer.com/content/pdf/10.1186/s13063-021-05854-w.pdf https://link.springer.com/article/10.1186/s13063-021-05854-w/fulltext.html |
geographic |
New Zealand |
geographic_facet |
New Zealand |
genre |
First Nations |
genre_facet |
First Nations |
op_source |
Trials volume 22, issue 1 ISSN 1745-6215 |
op_rights |
https://creativecommons.org/licenses/by/4.0 https://creativecommons.org/licenses/by/4.0 |
op_rightsnorm |
CC-BY |
op_doi |
https://doi.org/10.1186/s13063-021-05854-w |
container_title |
Trials |
container_volume |
22 |
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1 |
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1766001063831273472 |