Expanded Hemodialysis With Theranova® Compared to Conventional High-flux Hemodialysis: A Prospective Randomized 12-month Study.

Abstract

Background: Expanded hemodialysis using medium cut-off (MCO) dialyzer enables higher clearance of larger middle molecules. A twice-weekly hemodialysis (HD) regimen is commonly adopted in Hong Kong. This study compared the effect of MCO-HD versus high-flux HD for 12 months on clinical and patient reported outcomes and biomarkers related to nutritional status, inflammation and cardiovascular health with high-flux HD, with over 60% of patients on twice weekly HD.

Methods: Stable HD patients, after 6 weeks of high-flux HD run-in, were randomized (1:1) to continue high-flux HD (Control group) or change to MCO-HD with Theranova® dialyzer and observed for 12 months.

Results: Sixty patients were randomized (30:30), with 60% on twice-weekly HD. Body mass index, lean and fat tissue indexes remained stable throughout, with no within- or between-group difference. Serum albumin showed a transient decrease in the MCO-HD group, with 6-month value significantly lower than baseline (3.62±0.34 vs. 3.79±0.28g/dL, p=0.043) and that in Controls (3.84±0.34g/dL, p=0.024), before it increased back to baseline level. At 12-month, the two groups showed similar laboratory parameters and patient-reported outcomes related to sleep quality, appetite, itchiness, and quality of life. There was no consistent change in biomarkers related to inflammation and cardiovascular health. The incidence rate of adverse events, cardiovascular events, infection rate and hospitalization rates were similar in the two groups.

Conclusions: MCO-HD was safe and well-tolerated and, except for an initial decrease of serum albumin at 6 months which subsequently returned to baseline. It was not associated with significant differences in clinical and nutritional parameters, patient-reported outcomes, inflammatory/cardiovascular biomarkers and adverse clinical event rates in patients on twice weekly HD.