Expanded Hemodialysis with Theranova Compared with Conventional High-Flux Hemodialysis: Prospective Randomized 12-Month Study.

KEY POINTS

This randomized controlled trial confirms that medium cutoff hemodialysis (MCO-HD) was safe and well tolerated over a 12-month period in patients on twice-weekly hemodialysis. MCO-HD was associated with a transient reduction of serum albumin level for ≤6 months and was not associated with adverse clinical events. MCO-HD did not add significant benefit to clinical parameters compared with high-flux hemodialysis in patients on a relatively lower dialysis dose.

BACKGROUND

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

METHODS

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

RESULTS

Sixty patients were randomized (30:30), with 60% on twice-weekly hemodialysis. Body mass index, lean, and fat tissue indexes remained stable throughout, with no within-group or between-group differences. Serum albumin showed a transient decrease in the MCO-HD group, with 6-month value significantly lower than baseline (3.62±0.34 versus 3.79±0.28 g/dl, = 0.043) and that in controls (3.84±0.34g/dl, = 0.024) before it increased back to the baseline level. At 12 months, 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 was similar in the two groups.

CONCLUSIONS

MCO-HD was safe and well-tolerated 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 hemodialysis.

CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER

: NCT04106310.