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

Area of Science:

• Nephrology
• Renal Replacement Therapy
• Dialysis Technology

Background:

• Expanded hemodialysis (HD) with medium cut-off (MCO) dialyzers enhances clearance of larger middle molecules.
• A twice-weekly HD regimen is common in Hong Kong.
• This study compared MCO-HD with high-flux HD in patients on a twice-weekly schedule.

Purpose of the Study:

• To compare the 12-month clinical outcomes of MCO-HD versus high-flux HD.
• To assess patient-reported outcomes, including nutritional status, inflammation, and cardiovascular health.
• To evaluate the safety and tolerability of MCO-HD in a twice-weekly HD regimen.

Main Methods:

• Stable HD patients were randomized to continue high-flux HD (Control) or switch to MCO-HD using Theranova® dialyzers.
• The study included a 6-week high-flux HD run-in period.
• Patients were observed for 12 months, with 60% on a twice-weekly HD schedule.

Main Results:

• No significant differences were observed in body mass index, lean, or fat tissue indexes between groups.
• Serum albumin showed a transient decrease at 6 months in the MCO-HD group, returning to baseline by 12 months.
• Laboratory parameters, patient-reported outcomes, inflammatory/cardiovascular biomarkers, and adverse event rates were similar between the MCO-HD and control groups at 12 months.

Conclusions:

• Medium cut-off (MCO) hemodialysis (HD) is safe and well-tolerated for patients on a twice-weekly schedule.
• MCO-HD did not result in significant differences in clinical, nutritional, or patient-reported outcomes compared to high-flux HD.
• An initial transient decrease in serum albumin was observed with MCO-HD but resolved by study completion.