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Efficacy and Safety of Super High-Flux Hemodialysis in Maintenance Dialysis Patients. SHINE-RLS (Super High-flux Dialysis Improves Neuro-symptoms and Efficacy in Restless Legs Syndrome)

NCT07794826 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-08-31

No results posted yet for this study

Summary

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.

Conditions

  • End Stage Renal Failure, Hemodialysis
  • Restless Leg Syndrome (RLS)

Interventions

DEVICE

Super High-Flux HD

Participants 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.

Sponsors & Collaborators

  • Far Eastern Memorial Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2027-09-30
Completion
2029-09-30

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07794826 on ClinicalTrials.gov