Efficacy and safety of novel polyethersulfone dialyzers: a multicenter, randomized, crossover study.

BACKGROUND

The continuous rise in healthcare costs associated with hemodialysis has become a growing concern in South Korea, where hemodialysis is the predominant treatment modality for end-stage kidney disease. Currently, all dialyzers are imported, underscoring the need for domestically manufactured alternatives. This study aims to evaluate the clinical efficacy and safety of a domestically produced novel polyethersulfone dialyzer.

METHODS

This multicenter, randomized, crossover clinical trial evaluated the non-inferiority of the Synoflux series dialyzer (Synopex Inc.) compared to the commercially available FX Classix dialyzer (Fresenius Medical Care) in maintenance hemodialysis patients. Each patient was randomly assigned to one of two treatment sequences, receiving each dialyzer for 4 weeks in a crossover design. The primary endpoints were the urea reduction ratio (URR) and single-pool Kt/V (spKt/V). Secondary endpoints included the clearance of middle molecules and safety outcomes.

RESULTS

The Synoflux series dialyzer met the non-inferiority criteria for both URR (mean difference, -1.29%; 95% confidence interval [CI], -2.01 to -0.58) and spKt/V (mean difference, -0.06; 95% CI, -0.10 to -0.02). It demonstrated superior clearance of middle-molecule solutes, including cystatin C, β2-microglobulin, and prolactin. No serious adverse events related to the dialyzer were reported, and the frequency of hypotension or clotting events was comparable between the dialyzers.

CONCLUSION

The Synoflux series dialyzer demonstrated non-inferior efficacy and acceptable safety compared to the widely used FX Classix dialyzer, thereby supporting its clinical applicability as a domestically produced alternative for maintenance hemodialysis.