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. 2023 May 27;16(11):2254-2261.
doi: 10.1093/ckj/sfad128. eCollection 2023 Nov.

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  1 , Rafael Pérez-García  1 , Almudena Vega  2 , Shaira Martínez-Vaquera  3 , Jesús Guillermo Acosta  4 , Katia Pérez Del Valle  5 , Milagros Fernández-Lucas  6 , María Antonia García-Rubiales  7 , Antonio Luis García-Herrera  8 , Elisabeth Coll  9 , Evangelina Mérida  10 , Patricia Martínez-Miguel  11 , Itziar Castaño  12 , Beatriz Gil-Casares  13 , Julia Garro  14 , Francisco Maduell  15 ; MOTheR collaborative network
Collaborators, Affiliations

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 et al. Clin Kidney J. .

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.

Keywords: cardiovascular events; expanded hemodialysis (HDx); medium cut-off membranes (MCO); mortality; online hemodiafiltration (OL-HDF).

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Conflict of interest statement

P.d.S. reports honorarium for conferences, consulting fees and advisory boards from Amgen, Astellas, AstraZeneca, Baxter, Braun, Fresenius Medical Care, GlaxoSmithKline, Nipro, Otsuka, Sandoz, Nipro and Vifor-Pharma. She is the present president of the Spanish Society of Nephrology (S.E.N.). R.P.-G. reports honorarium from Nipro. A.V. has received consultancy fees and lecture fees from Baxter, Braun and Astellas. P.M.-M. report honorarium for conferences and consulting fee from Nipro. M.F.-L. reports honorarium for conferences from Nipro. E.C. reports honorarium for conferences from Fresenius, Astellas and AstraZeneca, and studies from Baxter. I.C. reports honorarium for conferences from Braun, Palex and Vifor Pharma. F.M. has received consultancy fees and lecture fees from Baxter, Fresenius Medical Care, Medtronic, Nipro, Toray and Vifor. K.P.d.V., A.L.G.-H., J.G., M.A.G.-R., E.M. and B.G.-C. have no conflicts of interest.

Figures

Graphical Abstract
Graphical Abstract
Figure 1:
Figure 1:
Schematic overview of the MoTHER HDx study.
See this image and copyright information in PMC

References

    1. Vanholder R, De Smet R, Glorieux Get al. . European Uremic Toxin Work Group (EUTox) . Review on uremic toxins: classification, concentration, and inter individual variability. Kidney Int 2003;63:1934–43. 10.1046/j.1523-1755.2003.00924.x - DOI - PubMed
    1. Vanholder R, Pletinck A, Schepers Eet al. . Biochemical and clinical impact of organic uremic retention solutes: a comprehensive update. Toxins (Basel) 2018;10:33. 10.3390/toxins10010033 - DOI - PMC - PubMed
    1. Wolley MJ, Hutchison CA. Large uremic toxins: an unsolved problem in end-stage kidney disease. Nephrol Dial Transplant 2018;33:6–11. 10.1093/ndt/gfy179 - DOI - PMC - PubMed
    1. Cozzolino M, Galassi A, Pivari Fet al. . The cardiovascular burden in end-stage renal disease. Contrib Nephrol 2017;191:44–57. 10.1159/000479250 - DOI - PubMed
    1. Dai L, Golembiewska E, Lindholm Bet al. . End-stage renal disease, inflammation and cardiovascular outcomes. Contrib Nephrol 2017;191:32–43. 10.1159/000479254 - DOI - PubMed