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...
Guardado en:
| Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Formato: | article |
| Lenguaje: | EN |
| Publicado: |
BMC
2021
|
| Materias: | |
| Acceso en línea: | https://doaj.org/article/1a24ef81047e499fa808e6646b9d55da |
| Etiquetas: |
Agregar Etiqueta
Sin Etiquetas, Sea el primero en etiquetar este registro!
|
| id |
oai:doaj.org-article:1a24ef81047e499fa808e6646b9d55da |
|---|---|
| record_format |
dspace |
| spelling |
oai:doaj.org-article:1a24ef81047e499fa808e6646b9d55da2021-12-05T12:19:56ZINFERR-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 trial10.1186/s13063-021-05854-w1745-6215https://doaj.org/article/1a24ef81047e499fa808e6646b9d55da2021-12-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05854-whttps://doaj.org/toc/1745-6215Abstract 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.Sandawana William MajoniJane NelsonDarren GermaineLibby HoppoStephanie LongShilpa DivakaranBrandon TurnerJessica GrahamSajiv CherianBasant PawarGeetha RathnayakeBianca HeronLouise Maple-BrownRobert BateyPeter MorrisJane DaviesDavid ( Kiran) FernandesMadhivanan SundaramAsanga AbeyaratneYun Hui Sheryl WongPaul D. LawtonSean TaylorFederica BarziAlan Cassfor the INFERR study GroupBMCarticleAboriginal and Torres Strait Islander AustraliansFirst Nations AustraliansAnaemiaChronic kidney diseaseMaintenance haemodialysisFerritinMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-21 (2021) |
| institution |
DOAJ |
| collection |
DOAJ |
| language |
EN |
| topic |
Aboriginal and Torres Strait Islander Australians First Nations Australians Anaemia Chronic kidney disease Maintenance haemodialysis Ferritin Medicine (General) R5-920 |
| spellingShingle |
Aboriginal and Torres Strait Islander Australians First Nations Australians Anaemia Chronic kidney disease Maintenance haemodialysis Ferritin Medicine (General) R5-920 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 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 |
| 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. |
| format |
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 |
| author_facet |
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 |
| author_sort |
Sandawana William Majoni |
| 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 |
BMC |
| publishDate |
2021 |
| url |
https://doaj.org/article/1a24ef81047e499fa808e6646b9d55da |
| work_keys_str_mv |
AT sandawanawilliammajoni inferrironinfusioninhaemodialysisstudyintravenousironpolymaltoseforfirstnationsaustralianpatientswithhighferritinlevelsonhaemodialysisaprotocolforaprospectiveopenlabelblindedendpointrandomisedcontrolledtrial AT janenelson inferrironinfusioninhaemodialysisstudyintravenousironpolymaltoseforfirstnationsaustralianpatientswithhighferritinlevelsonhaemodialysisaprotocolforaprospectiveopenlabelblindedendpointrandomisedcontrolledtrial AT darrengermaine inferrironinfusioninhaemodialysisstudyintravenousironpolymaltoseforfirstnationsaustralianpatientswithhighferritinlevelsonhaemodialysisaprotocolforaprospectiveopenlabelblindedendpointrandomisedcontrolledtrial AT libbyhoppo inferrironinfusioninhaemodialysisstudyintravenousironpolymaltoseforfirstnationsaustralianpatientswithhighferritinlevelsonhaemodialysisaprotocolforaprospectiveopenlabelblindedendpointrandomisedcontrolledtrial AT stephanielong inferrironinfusioninhaemodialysisstudyintravenousironpolymaltoseforfirstnationsaustralianpatientswithhighferritinlevelsonhaemodialysisaprotocolforaprospectiveopenlabelblindedendpointrandomisedcontrolledtrial AT shilpadivakaran inferrironinfusioninhaemodialysisstudyintravenousironpolymaltoseforfirstnationsaustralianpatientswithhighferritinlevelsonhaemodialysisaprotocolforaprospectiveopenlabelblindedendpointrandomisedcontrolledtrial AT brandonturner inferrironinfusioninhaemodialysisstudyintravenousironpolymaltoseforfirstnationsaustralianpatientswithhighferritinlevelsonhaemodialysisaprotocolforaprospectiveopenlabelblindedendpointrandomisedcontrolledtrial AT jessicagraham inferrironinfusioninhaemodialysisstudyintravenousironpolymaltoseforfirstnationsaustralianpatientswithhighferritinlevelsonhaemodialysisaprotocolforaprospectiveopenlabelblindedendpointrandomisedcontrolledtrial AT sajivcherian inferrironinfusioninhaemodialysisstudyintravenousironpolymaltoseforfirstnationsaustralianpatientswithhighferritinlevelsonhaemodialysisaprotocolforaprospectiveopenlabelblindedendpointrandomisedcontrolledtrial AT basantpawar inferrironinfusioninhaemodialysisstudyintravenousironpolymaltoseforfirstnationsaustralianpatientswithhighferritinlevelsonhaemodialysisaprotocolforaprospectiveopenlabelblindedendpointrandomisedcontrolledtrial AT geetharathnayake inferrironinfusioninhaemodialysisstudyintravenousironpolymaltoseforfirstnationsaustralianpatientswithhighferritinlevelsonhaemodialysisaprotocolforaprospectiveopenlabelblindedendpointrandomisedcontrolledtrial AT biancaheron inferrironinfusioninhaemodialysisstudyintravenousironpolymaltoseforfirstnationsaustralianpatientswithhighferritinlevelsonhaemodialysisaprotocolforaprospectiveopenlabelblindedendpointrandomisedcontrolledtrial AT louisemaplebrown inferrironinfusioninhaemodialysisstudyintravenousironpolymaltoseforfirstnationsaustralianpatientswithhighferritinlevelsonhaemodialysisaprotocolforaprospectiveopenlabelblindedendpointrandomisedcontrolledtrial AT robertbatey inferrironinfusioninhaemodialysisstudyintravenousironpolymaltoseforfirstnationsaustralianpatientswithhighferritinlevelsonhaemodialysisaprotocolforaprospectiveopenlabelblindedendpointrandomisedcontrolledtrial AT petermorris inferrironinfusioninhaemodialysisstudyintravenousironpolymaltoseforfirstnationsaustralianpatientswithhighferritinlevelsonhaemodialysisaprotocolforaprospectiveopenlabelblindedendpointrandomisedcontrolledtrial AT janedavies inferrironinfusioninhaemodialysisstudyintravenousironpolymaltoseforfirstnationsaustralianpatientswithhighferritinlevelsonhaemodialysisaprotocolforaprospectiveopenlabelblindedendpointrandomisedcontrolledtrial AT davidkiranfernandes inferrironinfusioninhaemodialysisstudyintravenousironpolymaltoseforfirstnationsaustralianpatientswithhighferritinlevelsonhaemodialysisaprotocolforaprospectiveopenlabelblindedendpointrandomisedcontrolledtrial AT madhivanansundaram inferrironinfusioninhaemodialysisstudyintravenousironpolymaltoseforfirstnationsaustralianpatientswithhighferritinlevelsonhaemodialysisaprotocolforaprospectiveopenlabelblindedendpointrandomisedcontrolledtrial AT asangaabeyaratne inferrironinfusioninhaemodialysisstudyintravenousironpolymaltoseforfirstnationsaustralianpatientswithhighferritinlevelsonhaemodialysisaprotocolforaprospectiveopenlabelblindedendpointrandomisedcontrolledtrial AT yunhuisherylwong inferrironinfusioninhaemodialysisstudyintravenousironpolymaltoseforfirstnationsaustralianpatientswithhighferritinlevelsonhaemodialysisaprotocolforaprospectiveopenlabelblindedendpointrandomisedcontrolledtrial AT pauldlawton inferrironinfusioninhaemodialysisstudyintravenousironpolymaltoseforfirstnationsaustralianpatientswithhighferritinlevelsonhaemodialysisaprotocolforaprospectiveopenlabelblindedendpointrandomisedcontrolledtrial AT seantaylor inferrironinfusioninhaemodialysisstudyintravenousironpolymaltoseforfirstnationsaustralianpatientswithhighferritinlevelsonhaemodialysisaprotocolforaprospectiveopenlabelblindedendpointrandomisedcontrolledtrial AT federicabarzi inferrironinfusioninhaemodialysisstudyintravenousironpolymaltoseforfirstnationsaustralianpatientswithhighferritinlevelsonhaemodialysisaprotocolforaprospectiveopenlabelblindedendpointrandomisedcontrolledtrial AT alancass inferrironinfusioninhaemodialysisstudyintravenousironpolymaltoseforfirstnationsaustralianpatientswithhighferritinlevelsonhaemodialysisaprotocolforaprospectiveopenlabelblindedendpointrandomisedcontrolledtrial AT fortheinferrstudygroup inferrironinfusioninhaemodialysisstudyintravenousironpolymaltoseforfirstnationsaustralianpatientswithhighferritinlevelsonhaemodialysisaprotocolforaprospectiveopenlabelblindedendpointrandomisedcontrolledtrial |
| _version_ |
1718372002540027904 |