Trial design of the MOTheR HDx study : a multicenter, open-label, prospective, randomized study to explore the morbidity and mortality in patients dialyzed with the Theranova HDx in comparison with online hemodiafiltration
© The Author(s) 2023. Published by Oxford University Press on behalf of the ERA..
Background: Dialysis patients have been maintaining a high rate of cardiovascular morbidity and mortality. For this reason, it is to introduce necessary new technical advances in clinical practice. There is a relation between toxins retention and inflammation, mortality and morbidity. Medium cut-off (MCO) membranes are a new generation of membranes that allow the removal of a greater number of medium-sized molecules compared with high-flux hemodialysis (HF-HD), but retaining albumin. MCO membranes have an increased permeability and the presence of internal filtration. Because of these special properties, MCO generated a new concept of therapy called expanded HD (HDx). Until now, online hemodiafiltration (OL-HDF) has demonstrated its superiority, in terms of survival, compared with HF-HD. However, the comparison between OL-HDF and HDx remains an unsolved question.
Methods: The MOTheR HDx study trial (NCT03714386) is an open-label, multicenter, prospective, 1:1 randomized, parallel-group trial designed to evaluate the efficacy and safety of HDx compared with OL-HDF in patients treated for dialysis in Spain for up to 36 months. The main endpoint is to determinate whether HDx is non inferior to OL-HDF at reducing the combined outcome of all-cause death and stroke (ischemic or hemorrhagic), acute coronary syndrome (angina and myocardial infarction), peripheral arterial disease (amputation or revascularization) and ischemic colitis (mesenteric thrombosis).
Results: The trial has already started.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:16 |
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| Enthalten in: |
Clinical kidney journal - 16(2023), 11 vom: 14. Nov., Seite 2254-2261 |
| Sprache: |
Englisch |
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| Links: |
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| Themen: |
Cardiovascular events |
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| Anmerkungen: |
Date Revised 03.11.2023 published: Electronic-eCollection Citation Status PubMed-not-MEDLINE |
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| doi: |
10.1093/ckj/sfad128 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM364078308 |
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| 100 | 1 | |a de Sequera, Patricia |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Trial design of the MOTheR HDx study |b a multicenter, open-label, prospective, randomized study to explore the morbidity and mortality in patients dialyzed with the Theranova HDx in comparison with online hemodiafiltration |
| 264 | 1 | |c 2023 | |
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| 500 | |a Date Revised 03.11.2023 | ||
| 500 | |a published: Electronic-eCollection | ||
| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a © The Author(s) 2023. Published by Oxford University Press on behalf of the ERA. | ||
| 520 | |a Background: Dialysis patients have been maintaining a high rate of cardiovascular morbidity and mortality. For this reason, it is to introduce necessary new technical advances in clinical practice. There is a relation between toxins retention and inflammation, mortality and morbidity. Medium cut-off (MCO) membranes are a new generation of membranes that allow the removal of a greater number of medium-sized molecules compared with high-flux hemodialysis (HF-HD), but retaining albumin. MCO membranes have an increased permeability and the presence of internal filtration. Because of these special properties, MCO generated a new concept of therapy called expanded HD (HDx). Until now, online hemodiafiltration (OL-HDF) has demonstrated its superiority, in terms of survival, compared with HF-HD. However, the comparison between OL-HDF and HDx remains an unsolved question | ||
| 520 | |a Methods: The MOTheR HDx study trial (NCT03714386) is an open-label, multicenter, prospective, 1:1 randomized, parallel-group trial designed to evaluate the efficacy and safety of HDx compared with OL-HDF in patients treated for dialysis in Spain for up to 36 months. The main endpoint is to determinate whether HDx is non inferior to OL-HDF at reducing the combined outcome of all-cause death and stroke (ischemic or hemorrhagic), acute coronary syndrome (angina and myocardial infarction), peripheral arterial disease (amputation or revascularization) and ischemic colitis (mesenteric thrombosis) | ||
| 520 | |a Results: The trial has already started | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a cardiovascular events | |
| 650 | 4 | |a expanded hemodialysis (HDx) | |
| 650 | 4 | |a medium cut-off membranes (MCO) | |
| 650 | 4 | |a mortality | |
| 650 | 4 | |a online hemodiafiltration (OL-HDF) | |
| 700 | 1 | |a Pérez-García, Rafael |e verfasserin |4 aut | |
| 700 | 1 | |a Vega, Almudena |e verfasserin |4 aut | |
| 700 | 1 | |a Martínez-Vaquera, Shaira |e verfasserin |4 aut | |
| 700 | 1 | |a Acosta, Jesús Guillermo |e verfasserin |4 aut | |
| 700 | 1 | |a Pérez Del Valle, Katia |e verfasserin |4 aut | |
| 700 | 1 | |a Fernández-Lucas, Milagros |e verfasserin |4 aut | |
| 700 | 1 | |a García-Rubiales, María Antonia |e verfasserin |4 aut | |
| 700 | 1 | |a García-Herrera, Antonio Luis |e verfasserin |4 aut | |
| 700 | 1 | |a Coll, Elisabeth |e verfasserin |4 aut | |
| 700 | 1 | |a Mérida, Evangelina |e verfasserin |4 aut | |
| 700 | 1 | |a Martínez-Miguel, Patricia |e verfasserin |4 aut | |
| 700 | 1 | |a Castaño, Itziar |e verfasserin |4 aut | |
| 700 | 1 | |a Gil-Casares, Beatriz |e verfasserin |4 aut | |
| 700 | 1 | |a Garro, Julia |e verfasserin |4 aut | |
| 700 | 1 | |a Maduell, Francisco |e verfasserin |4 aut | |
| 700 | 0 | |a MOTheR collaborative network |e verfasserin |4 aut | |
| 700 | 1 | |a de Sequera, Patricia |e investigator |4 oth | |
| 700 | 1 | |a Jaldo, María Teresa |e investigator |4 oth | |
| 700 | 1 | |a Puerta, Marta |e investigator |4 oth | |
| 700 | 1 | |a Medina, Laura |e investigator |4 oth | |
| 700 | 1 | |a Vega, Almudena |e investigator |4 oth | |
| 700 | 1 | |a Abad, Soraya |e investigator |4 oth | |
| 700 | 1 | |a Macías, Nicolás |e investigator |4 oth | |
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| 700 | 1 | |a Lamas, Elena Iglesias |e investigator |4 oth | |
| 700 | 1 | |a López, Maria Crucio |e investigator |4 oth | |
| 700 | 1 | |a Lucas, Milagros Fernández |e investigator |4 oth | |
| 700 | 1 | |a Mendiola, Nuria Rodríguez |e investigator |4 oth | |
| 700 | 1 | |a Domínguez, Martha Elizabeth Díaz |e investigator |4 oth | |
| 700 | 1 | |a Roso, Gloria Ruíz |e investigator |4 oth | |
| 700 | 1 | |a Maduell, Francisco |e investigator |4 oth | |
| 700 | 1 | |a Broseta, José Jesús |e investigator |4 oth | |
| 700 | 1 | |a Arias-Guillen, Marta |e investigator |4 oth | |
| 700 | 1 | |a Rodas, Lida María |e investigator |4 oth | |
| 700 | 1 | |a Piñera, Celestino |e investigator |4 oth | |
| 700 | 1 | |a Kislikova, María |e investigator |4 oth | |
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| 700 | 1 | |a Puerto, Ana Isabel Martínez |e investigator |4 oth | |
| 700 | 1 | |a Salgueira, Mercedes |e investigator |4 oth | |
| 700 | 1 | |a Herrera, Antonio Luis García |e investigator |4 oth | |
| 700 | 1 | |a Lancho, Carolina |e investigator |4 oth | |
| 700 | 1 | |a De La Espada, Verónica |e investigator |4 oth | |
| 700 | 1 | |a Roselló, Carmen Peralta |e investigator |4 oth | |
| 700 | 1 | |a Company, Joan Manuel Gascó |e investigator |4 oth | |
| 700 | 1 | |a Rubiales, María Antonia García |e investigator |4 oth | |
| 700 | 1 | |a Guinea, Marta Torres |e investigator |4 oth | |
| 700 | 1 | |a Pajares, Elena Pascual |e investigator |4 oth | |
| 700 | 1 | |a Ruiz, Begoña Rincón |e investigator |4 oth | |
| 700 | 1 | |a Rebollo, Mª Del Sagrario García |e investigator |4 oth | |
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| 700 | 1 | |a Rodríguez, Nieves Del Castillo |e investigator |4 oth | |
| 700 | 1 | |a Coll, Elisabet |e investigator |4 oth | |
| 700 | 1 | |a Diaz, Juan Manuel |e investigator |4 oth | |
| 700 | 1 | |a Lloret, María Jesús |e investigator |4 oth | |
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| 700 | 1 | |a Visus, Teresa |e investigator |4 oth | |
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| 700 | 1 | |a Fernández Fernández, Raquel |e investigator |4 oth | |
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| 700 | 1 | |a Loza, Emma Huarte |e investigator |4 oth | |
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