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
Authors: 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 ,   the MOTheR collaborative network, de Sequera Patricia , Jaldo María Teresa , Puerta Marta , Medina Laura , Vega Almudena , Abad Soraya , Macías Nicolás , García Ana , Pérez Del Valle Katia , Álamo Concepción , Heras Marta Sánchez , Lamas Elena Iglesias , López Maria Crucio , Lucas Milagros Fernández , Mendiola Nuria Rodríguez , Domínguez Martha Elizabeth Díaz , Roso Gloria Ruíz , Maduell Francisco , Broseta José Jesús , Arias-Guillen Marta , Rodas Lida María , Piñera Celestino , Kislikova María , Esquivias Elvira , Puerto Ana Isabel Martínez , Salgueira Mercedes , Herrera Antonio Luis García , Lancho Carolina , De La Espada Verónica , Roselló Carmen Peralta , Company Joan Manuel Gascó , Rubiales María Antonia García , Guinea Marta Torres , Pajares Elena Pascual , Ruiz Begoña Rincón , Rebollo Mª Del Sagrario García , Cabrera Beatriz Escamilla , Rodríguez Nieves Del Castillo , Coll Elisabet , Diaz Juan Manuel , Lloret María Jesús , Enríquez Alba García , Mérida Evangelina , Fernández María , Aubert Lucia , Costoso Laura Espinel , Miguel Patricia Martínez , Bouarich Hanane , Fernández María Pérez , Gallego Eduardo , Gruss Enrique , Sánchez Sánchez María , Berrón Juan Carlos Herrero , Villalobos Angel Gallego , Martín Francisco , Larrañaga Oihana , Visus Teresa , Falcón Teresa García , García Carmen Pallares , Lago Mª Del Mar , Castaño Itziar , Manrique Joaquín , Garcia-Fernandez Nuria , López Raquel Ojeda , Castellote Eugenia , Guasch Bernat , Etaaboudi Samia , Martínez Julia Garros , Pulido Lisset Josefina , Huertas Beatriz Fuentes , Gil-Casares Beatriz , Tornero Fernando , Bautista José María , Visbal Jesús Guillermo Acosta , Sánchez Yarelys León , Rojas Ruth Amair , Fernández Fernández Raquel , Alarcón Walter López , Paraíso Antonio Gil , Loza Emma Huarte , Morillo-Velarde Rocío Vidal , Portoles José María , Llopez-Carratala Mª Rosario , Ruiz-Calero Rosa M , Hidalgo Martin , Álvarez Álvaro , Planas Antonio Francisco , Mosquera Mónica , Uriarte Oscar García , Alba Alejandro Pérez , De La Manzanara Virginia López , Estifan Jorge , García Elena Hernández , García Ana Isabel Morales , Merino José Carlos De La Flor , Grávalos Tania Linares , Martínez-Vaquera Shaira , León José Luis Pizarro , Herrador Alejandro Jiménez , Díaz Álvarez Leonardo , Alcántara Antonio Romero , Moya Juan De Dios Ramiro , Gómez Lidia Diaz , Jiménez Benaldina García , Vico Raúl Orihuela , Alonso Rocío Leiva , Pérez Nathasha Carolina Nava , Mantecón Carlos Jarava , Quiceno Marta Uvieli García , Bravo Jesús Domínguez , Alvarenga Scarleth Elizabeth Flores , García Manuel Antonio Martínez , Viñes Paula Aledón , Bonilla Gustavo Useche , Pérez Ángel García , Utrera Brenda Henningsmeyer , Pascual Olga Martínez , Cupeiro María Otero , Cameselle Verónica Pesqueira , Sainz Marta Sanz , Catalá Yamila Saharaui , Franco Antonio Marín 
Published: May 2023

ABSTRACT

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.