#3944 COMPARISON OF CLINICAL PERFORMANCE AND HEMOCOMPATIBILITY OF DIALYZERS APPLIED DURING POST-DILUTION ONLINE HEMODIAFILTRATION (HDF) – EMPORA III STUDY

Abstract Background and Aims Performance hemocompatibility are the two main functions of a hemodialyzer. Synthetic dialysis membranes made from polysulfone (PSU) or polyethersulfone (PES) mainly used for treatments blended with hydrophilic agent polyvinylpyrrolidone (PVP), to improve during treatments. A novel PSU-based dialyzer (FX CorAL) an increased stabilized PVP content has been developed shown strong performance favourable profile within previous short term clinical studies. In present study, we now investigated FX CorAL vs. comparators over longer follow-up time applied extended panel biomarkers. This allowed us analyse treatment-specific as well extensive intra- interdialytic profile. Method eMPORA III was prospective, open, controlled, multicentre crossover trial randomized treatment sequences conducted in DE, CZ HU. It stable patients receiving regular post-dilution online HDF 600, CorDiax 600 (both Fresenius Medical Care) xevonta Hi 15 (B. Braun), each 4 weeks. The primary outcome β2-m removal rate (RR) hrs HDF. Non-inferiority (margin: 5%) superiority versus were tested at α = 2.5% (one-sided), adjustment multiple tests. Secondary endpoints RR and/or clearance other molecules, changes markers complement activation (C3a, sC5b-9), cell / inflammation (white blood cells (WBC), PMN elastase, IL-6, IL-8, LTB-4, sICAM-1, hsCRP), platelet (platelet count, β-TG, TxB-2), oxidative stress (MDA, GSH-Px). Intradialytic analysed descriptively differences values determined start session (LS means). Results Eighty-two included safety population, n 76 presenting data (ITT population). showed highest mean: 76.31%), followed by (75.71%) (74.49%). its statistically significant (p<0.0001 each). Superiority (p<0.0001), but not (p 0.0606). secondary myoglobin affirmed these results; small molecule clearances similar between dialyzers. Analyses one session, found following differences: Complement • C3a min: CorAL: 31%; CorDiax: 59% 0.003 CorAL); xevonta: 41% 0.029 sC5b-9 60 24%; 25% 0.337); (p<0.0001) Cell activation/ Inflammation WBC -7.7%; -11.1% 0.015); -10.1% 0.246) Monocytes -30.9%; -30.3% 0.533); -38.2% 0.012) Neutrophils -3.0%; -7.5% 0.019); -6.1% 0.258) elastase 18%; 42% 0.003); 52% 0.0003) LTB-4 170%; 217% 0.047); 186% 0.539) Platelet β-TG -15%; 4% (p<0.0001); 18% Hemocompatibility no changes, i.e., periods. Nine serious adverse events occurred this none which dialyser related. Conclusion efficiently removed middle molecules non-inferior both significantly superior RR. typical drop WBC, monocyte, neutrophil count rise sC5b-9) (PMN β-TG) lower comparable comparators, indicating properties.