• Medientyp: E-Artikel
  • Titel: 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
  • Beteiligte: de Sequera, Patricia; Pérez-García, Rafael; Vega, Almudena; Martínez-Vaquera, Shaira; Acosta, Jesús Guillermo; Pérez Del Valle, Katia; Fernández-Lucas, Milagros; García-Rubiales, María Antonia; García-Herrera, Antonio Luis; Coll, Elisabeth; Mérida, Evangelina; Martínez-Miguel, Patricia; Castaño, Itziar; Gil-Casares, Beatriz; Garro, Julia; Maduell, Francisco; de Sequera, Patricia; Jaldo, María Teresa; Puerta, Marta; Medina, Laura; Vega, Almudena; Abad, Soraya; Macías, Nicolás; García, Ana; [...]
  • Erschienen: Oxford University Press (OUP), 2023
  • Erschienen in: Clinical Kidney Journal
  • Sprache: Englisch
  • DOI: 10.1093/ckj/sfad128
  • ISSN: 2048-8505; 2048-8513
  • Schlagwörter: Transplantation ; Nephrology
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  • Beschreibung: <jats:title>ABSTRACT</jats:title> <jats:sec> <jats:title>Background</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods</jats:title> <jats:p>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).</jats:p> </jats:sec> <jats:sec> <jats:title>Results</jats:title> <jats:p>The trial has already started.</jats:p> </jats:sec>
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