Solute clearance and biocompatibility of a newly developed Korean polyethersulfone dialyzer: a multicenter, randomized, crossover study

Abstract The Synoflux series is a high-flux dialyzer developed in Korea with a modified polyethersulfone membrane designed to achieve performance comparable to that of established imported dialyzers. In this multicenter, randomized, open-label, crossover trial, 25 patients receiving maintenance hemodialysis were randomized to undergo six weeks each of dialysis using Synoflux and control (ELISIO) dialyzers; 24 completed the study and were included in the analysis. Efficacy was assessed by the urea reduction ratio (URR) and the reduction ratios of small and middle molecules. Safety endpoints included treatment-emergent adverse events, serum albumin preservation, changes in body weight and vital signs, and coagulation and complement parameters. Dialysis settings were comparable between the two phases. The mean URR was 70.25 ± 5.17% with Synoflux and 71.10 ± 4.30% with the control (mean difference − 0.81%; 95% CI, − 2.38 to 0.75), meeting the prespecified non-inferiority margin of − 5%. Both dialyzers achieved effective clearance of small molecules and similar removal of middle molecules. A higher cystatin C reduction ratio was observed with Synoflux in the high-flux subgroup. No serious treatment-emergent adverse events occurred, and serum albumin remained stable throughout both treatment periods. Small increases in complement components occurred with both dialyzers; these remained within the reference range, and were not accompanied by any complement-related adverse event. In this crossover trial, the Synoflux series demonstrated non-inferior efficacy and safety compared with a well-established dialyzer in maintenance hemodialysis. These findings warrant confirmation in larger, longer-term studies.