#3472 PRELIMINARY DATA FROM MOTHER HDX STUDY: A MULTICENTRE OPEN-LABEL RCT STUDY TO EXPLORE THE MORBIMORTALITY WITH THE THERANOVA HDX VS OL-HDF

Abstract

Abstract Background and Aims Dialysis patients have a high rate of cardiovascular morbidity and mortality. For this reason, new technical advances are necessary to be introduced in clinical practice. Medium cut-off (MCO) membranes are a new generation of membranes that allow the removal of a greater number of medium-sized molecules compared to high-flux hemodialysis (HF-HD) but retaining albumin. Theranova, a MCO membrane has an increased permeability and also produces high convective volume in the form of internal filtration. For 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 to HF-HD. But the comparison between OL-HDF and HDx is a question not solved. Method The MOTheR HDx study trial (NCT03714386) is an open-label, multicentric, prospective, 1:1 randomized, parallel-group trial designed to evaluate the efficacy and safety of HDx compared to OL-HDF in incident HD patients in Spain for up to 36 months. The main endpoint is to determinate if HDx is non inferior to OL-HDF at reducing the combined outcome of all-cause dead and stroke (ischemic or hemorrhagic), acute coronary syndrome (angina and myocardial infarction), peripheral arterial disease (amputation or revascularization) and ischemic colitis (mesenteric thrombosis). Results Now we have enrolled 513 patients, 44 excluded and 469 were randomized. 229 were allocated to HDx and 240 to OL-HDF. No differences were found in neither baseline characteristics, hemodialysis or pharmacological treatment, nor laboratory parameters. Follow up time was similar in both groups: 15.06 (12.8) vs 13.73 (11.51) months [HR 0.84 (0.50-1.40)] without differences in mortality: 29 (12.7%) vs 31 (12.9%) [HR 0.89 (0.54-1.48)] in HDx and HDF respectively (Figure 1). Conclusion These preliminary results from Mother study support that HDx is not inferior to OL-HDF in reducing the all-cause mortality outcome.