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
Patricia de Sequera, Rafael Pérez-García, Almudena Vega, Shaira Martínez-Vaquera, Jesús Guillermo Acosta, Katia Pérez del Valle, Milagros Fernández‐Lucas, María Antonia García-Rubiales, Antonio Luis García Herrera, Elisabeth Coll, Evangelina Mérida, Patricia Martínez‐Miguel, I. Albo Castaño, Beatriz Gil-Casares, Julia Garro, Francisco Maduell, the MOTheR collaborative network, Patricia de Sequera, María Teresa Jaldo, Marta Puerta, Laura Medina, Almudena Vega, Soraya Abad, Nicolás Macías, Ana Isabel Morales García, Katia Pérez Del Valle, Concepción Álamo, Marta Sánchez Heras, Elena Iglesias Lamas, María Crucio López, Milagros Fernández‐Lucas, Nuria Rodríguez Mendiola, Martha Elizabeth Díaz Domínguez, Gloria Ruíz Roso, Francisco Maduell, José Jesús Broseta, Marta Arias‐Guillén, Lida Rodas, Celestino Piñera, María Kislikova, Elvira Esquivias, Ana Isabel Martínez Puerto, Mercedes Salgueira, Antonio Luis García Herrera, Carolina Lancho, Verónica de la Espada, Carmen Peralta Roselló, María Antonia García Rubiales, Marta Torres Guinea, Elena Pascual Pajares, Begoña Rincón Ruiz, Ma Del Sagrario García Rebollo, Beatriz Escamilla Cabrera, Nieves Del Castillo Rodríguez, Elisabet Coll, Juan Manuel Garrido Díaz, María Jesús Lloret, Alba García Enríquez, Evangelina Mérida, María Pérez Fernández, L Aubert, Laura Espinel Costoso, Patricia Martínez‐Miguel, Hanane Bouarich, María Pérez Fernández, Eduardo Gallego, Enrique Gruss, María Sánchez Sánchez, Juan Carlos Herrero Berrón, Angel Gallego Villalobos, Francisco Martín, Oihana Larrañaga, Teresa Visus, Teresa García Falcón, Carmen Pallares García, Ma Del Mar Lago, I. Albo Castaño, Joaquín Manrique, Nuria Garcı́a-Fernández, Raquel Ojeda López, E. Castellote, Bernat Guasch, Samia Etaaboudi, Julia Garros Martínez, Lisset Josefina Pulido, Beatriz Huertas, Beatriz Gil-Casares, Fernando Tornero, José María Bautista, Jesús Guillermo Acosta Visbal, Yarelys León Sánchez, Ruth Amair Rojas, Raquel Fernández Fernández, Walter López Alarcón, Antonio Gil Paraíso, Emma Huarte Loza, R. Morillo-Velarde, Jose Pórtoles, M. Rosario Llópez-Carratalá, Rosa M Ruiz-Calero
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.