Comparison of High-Flux Hemodialysis Combined with KHA130 Hemoadsorption versus HA130 Hemoadsorption or Hemodiafiltration for Toxin Clearance.

INTRODUCTION

Effective removal of protein-bound and middle/large molecular toxins is essential in maintenance hemodialysis (HD). This study compared the efficacy of high-flux HD combined with KHA130 hemoadsorption (HA) cartridge against hemodiafiltration (HDF) and high-flux HD combined with the HA130 HA cartridge.

METHODS

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 additional 2 h of high-flux HD. The HDF group received 4 h of HDF 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.

RESULTS

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.

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.