Abstract
Background By inhibiting the adsorption of protein and platelets, surface-modifying macromolecules (SMMs) may improve the hemocompatibility of hemodialyzers. This trial aims to assess the performance and safety of a novel dialyzer with a fluorinated polyurethane SMM, Endexo™, blended into the membrane during manufacturing. Methods This prospective, sequential, multicenter, open-label study enrolled adults prescribed thrice-weekly hemodialysis. After completing 12 hemodialysis sessions with an Optiflux ® F160NR dialyzer , patients received 38 sessions with the dialyzer with Endexo. Evaluated parameters included the extent of removal of urea, albumin, and β2-microglobulin (β2M), as well as complement activation.Results Twenty-three patients received 268 hemodialysis treatments during the Optiflux period, and 18 patients continued on to receive 664 hemodialysis treatments during the Endexo period. Mean treatment times (208 vs 205 min), blood flow rates (447.7 vs 447.5 mL/min), dialysate flow rates (698.5 vs 698.0 mL/min), urea reduction ratio (82% vs 81%) and spKt/V (2.1 vs 1.9) were comparable for the Endexo and Optiflux periods, respectively. No overt complement activation was observed. Both dialyzers were associated with comparable mean increases in serum albumin levels from pre- to post- hemodialysis (Optiflux: 7.9%; Endexo: 8.0%). The corrected mean β2M removal rate was 47% higher during the Endexo period (67.73%). Three serious adverse events were reported, none of them device-related. Conclusions The performance of the novel dialyzer with Endexo was generally comparable to the Optiflux dialyzer, while exhibiting a higher β2M removal rate. Additional studies are needed to determine whether this novel dialyzer can be incorporated into heparin-free hemodialysis approaches.