Safety and performance of the Clearum™ high flux hemodialyzer

Abstract

AbstractBackgroundClearum™ is a high flux steam sterilized dialyzer for patients with hemodialysis or hemodiafiltration. This study evaluated the safety and performance of the Clearum high flux steam sterilized hemodialyzer in the removal of small and middle‐sized toxins.MethodsA prospective, interventional, nonrandomized study enrolled twenty end‐stage renal disease patients undergoing hemodialysis. The Clearum high flux steam sterilized dialyzer was compared to Fresenius FX dialyzers for baseline comparison. The duration of the trial was 2 weeks for the FX dialyzer and 6 weeks with the Clearum high flux steam sterilized dialyzer. In vitro studies with dextrans of varying sizes were performed to compare the membrane characteristics and sieving coefficient curves for the two dialyzers.ResultsThe primary objective of a mean urea reduction ratio >65% was met, with no significant difference in mean urea reduction ratio between the Clearum high flux steam sterilized and Fresenius FX‐series of dialyzers (p = 0.86). No dialyzer‐related adverse events were reported in the study. β‐2‐microglobulin reduction with the Clearum high flux steam sterilized dialyzer was statistically higher than the FX‐series dialyzer (66.5% vs. 53.6%; p < 0.0001). Predialysis interleukin‐6 and C‐reactive protein concentrations, blood‐rest scores (residual blood after blood restitution), and thrombin‐anti‐thrombin values were comparable. Albumin remained stable during the 6 weeks of Clearum high flux steam sterilized dialyzer use, with no appreciable differences compared to the Fresenius FX‐series.ConclusionThe Clearum high flux steam sterilized dialyzer showed good mid‐term effectivity for small and middle molecule removal with no reported dialyzer‐related adverse events.