Patients with end-stage kidney disease (ESKD) rely on maintenance hemodialysis. While high-flux hemodialysis improves small solute clearance, its removal of middle-molecule uremic toxins (e.g., α1-microglobulin \[α1-MG\]) remains insufficient, contributing to symptoms such as restless legs syndrome (RLS), pruritus, and poor sleep quality, which are also linked to increased cardiovascular risk. In this study, the investigators evaluate whether using a "Super High-Flux" dialyzer (a Type V high-performance dialyzer) during hemodialysis can safely improve the removal of middle-molecule uremic toxins-specifically α1-microglobulin (α1-MG)-and relieve RLS symptoms in maintenance hemodialysis patients.
Diagnosis of Restless Legs Syndrome according to standard criteria.
Age ≥ 20 years.
Maintenance high-flux hemodialysis for ≥ 3 months.
Stable vascular access (AV fistula or AV graft).
Low-flux HD or temporary catheter use
Serum albumin < 2.5 g/dL
Recent hospitalization (within 4 weeks)
Scheduled kidney transplantation
Crossover
Super High-Flux HD
DeviceParticipants receive hemodialysis using a Type V super high-flux dialyzer (such as Elisio™-HX or Theranova) for 12 weeks to assess the clearance of middle-molecule uremic toxins and its effect on RLS symptoms.
Change from Baseline in α1-microglobulin (α1-MG) Reduction Ratio
The reduction ratio of α1-MG will be calculated as \[({Pre-dialysis} - {Post-dialysis}) /{Pre-dialysis}\] at each study visit. The primary outcome is the difference in the change-from-baseline reduction ratio between the Super High-Flux HD period and the High-Flux HD period.
Change from Baseline in International Restless Legs Scale (IRLS) Score
IRLS score assesses the severity of Restless Legs Syndrome (ranging from 0 to 40, where higher scores indicate greater severity). Evaluated as the difference in score changes between the two treatment periods.
Change from Baseline in Pre-dialysis Serum Albumin Level
Monitored to evaluate nutritional safety and albumin preservation during Super High-Flux HD compared to High-Flux HD.
Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score
Assesses sleep quality. Evaluated as the difference in score changes between the two treatment periods.
Change from Baseline in 5-D Itch Scale Score
Assesses pruritus severity. Evaluated as the difference in score changes between the two treatment periods.
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