Abstract
INTRODUCTION: Expanded hemodialysis (HDx) enabled by Theranova increases the clearance of medium-sized molecules, improving clinical outcomes such as hospitalization and mortality. The objective of the study was to compare solute reduction ratios of medium-molecular-weight uremic toxins by HDx versus high-flux hemodialysis (HF-HD) with dialysate flow rates of 400 mL/min and 500 mL/min. METHODS: In 287 prevalent adult dialysis patients (mean age 61 years, 67% were men, 42.5% had diabetic kidney disease, and 16.7% had urine output ≥250 mL/day), the solute reduction ratio of circulating middle molecules was determined at 4 weeks and 12 weeks of follow-up in two cohorts, one with HDx (n = 137) and one with HF-HD (n = 150). A mixed-effects repeated measures model was used to evaluate differences between treatment groups. The frequencies of serious adverse events and hospitalization were also calculated. RESULTS: The HDx group achieved greater efficiency compared with HF-HD group in removing β2-microglobulin and free light chains (lambda and kappa); this superiority was statistically significant for both dialysate flow rates of 400 mL/min and 500 mL/min. We observed 25.9% fewer serious adverse events in the HDx cohort, none of which were causally related to the Theranova dialyzer or HF-HD treatment during 11,409 sessions. CONCLUSION: HDx enabled by Theranova dialyzer significantly improved the removal of medium-molecular-weight uremic toxins compared to HF-HD at dialysate flow rates of 500 mL/min and 400 ml/min, with fewer serious adverse events and hospitalization events. These findings support the use of the environmentally sustainable dialysis treatment of HDx with dialysate flow rate of 400 ml/min.