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
de Sequera, Patricia (Hospital Universitario Infanta Leonor)
Pérez-García, Rafael (Hospital Universitario Infanta Leonor)
Vega, Almudena (Hospital General Universitario Gregorio Marañón)
Martínez-Vaquera, Shaira (Diaverum)
Acosta Vélez, Juan Gabriel (Clínica Diálisis RTS)
Pérez Del Valle, Katia (Hospital Universitario de Guadalajara)
Fernández-Lucas, Milagros (Hospital Universitario Ramón y Cajal (Madrid))
García-Rubiales, María Antonia (Hospital Universitario Puerto Real (Cadis))
García-Herrera, Antonio Luis (Complejo Hospitalario de Toledo)
Coll, Elisabet (Institut d'Investigació Biomèdica Sant Pau)
Mérida, Evangelina (Hospital 12 de Octubre (Madrid))
Martínez-Miguel, Patricia (Hospital Universitario Alcalá de Henares)
Castaño, Itziar (Complejo Hospitalario de Navarra)
Gil-Casares, Beatriz (Hospital Universitario del Sureste)
Garro, Julia (Hospital Universitari Joan XXIII de Tarragona)
Maduell, Francisco (Hospital Clínic i Provincial de Barcelona)
Universitat Autònoma de Barcelona

Data:	2023
Resum:	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.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Cardiovascular events ; Expanded hemodialysis (HDx) ; Medium cut-off membranes (MCO) ; Mortality ; Online hemodiafiltration (OL-HDF)
Publicat a:	Clinical Kidney Journal, Vol. 16 Núm. 11 (january 2023) , p. 2254-2261, ISSN 2048-8513

DOI: 10.1093/ckj/sfad128
PMID: 37915938

8 p, 3.5 MB

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