Comparison of high-flux hemodialysis combined with KHA130 hemoadsorption versus HA130 hemoadsorption or hemodiafiltration for toxin clearance

Effective removal of protein-bound and middle/large molecular toxins is essential in maintenance hemodialysis. This study compared the efficacy of high-flux hemodialysis (HD) combined with KHA130 hemoadsorption (HA) cartridge against hemodiafiltration (HDF) and high-flux HD combined with the HA130 HA cartridge. Sixty patients were randomized to HDF group (n=20), HD+HA group (n=20), and HD+KHA group (n=20). HD+HA and HD+KHA groups received 2 h of HA followed by an additional 2 h of high-flux HD. The HDF group received 4 h of hemodiafiltration using the post-dilution mode. The primary endpoint was the single-session clearance rate of the protein-bound toxin p-cresyl sulfate (PCS), with a non-inferiority margin set at 10%. Secondary endpoints included clearance of indoxyl sulfate (IS), advanced glycation end products (AGEs), β2-microglobulin (β2-MG), and inflammatory factors. The results showed that baseline characteristics were comparable. For the primary endpoint of PCS clearance, HD+KHA was non-inferior to HDF and superior to HD+HA (P < 0.01). Results for secondary endpoints were less consistent: non-inferiority for IS and β2-MG clearance was observed only in unadjusted models, and no non-inferiority was observed for AGEs or inflammatory cytokines. Sensitivity analyses confirmed the robustness of the primary finding. No serious adverse events were reported. In conclusion, in this acute single-session biochemical study, the HD+KHA regimen met the criterion for non-inferiority to HDF and superiority to HD+HA for PCS clearance. However, given the exploratory nature of secondary and subgroup analyses, these findings require confirmation in larger, adequately powered studies with longer follow-up.