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 | Not Yet Recruiting

• 2 other identifiers: FEMH-IRB-TSAI2025FEMH-IIT-2026-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

End-stage kidney disease; Restless leg syndrome; Super high-flux hemodialysis

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Week 4, Week 8, and Week 12 of each 12-week treatment period

Secondary Outcomes (12)

• Change from Baseline in International Restless Legs Scale (IRLS) Score

  Baseline, Week 4, Week 8, and Week 12 of each 12-week treatment period

• Change from Baseline in Pre-dialysis Serum Albumin Level

  Baseline, Week 4, Week 8, and Week 12 of each 12-week treatment period

• Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score

  Baseline, Week 4, Week 8, and Week 12 of each 12-week treatment period

• Change from Baseline in 5-D Itch Scale Score

  Baseline, Week 4, Week 8, and Week 12 of each 12-week treatment period

• Change from Baseline in health-related quality of life (EQ-5D-5L) Score

  Baseline, Week 4, Week 8, and Week 12 of each 12-week treatment period

Study Arms (2)

Super High-Flux HD

EXPERIMENTAL

Receives 12 weeks of Super High-Flux HD (Elisio™-HX)

Device: Super High-Flux HD

High-Flux HD

NO INTERVENTION

Receives 12 weeks of High-Flux HD as usual care

Interventions

Super High-Flux HD DEVICE

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.

Super High-Flux HD

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Adequate dialysis delivery (URR ≥ 65% or Kt/V(daugirdes) ≥ 1.2).
• Sufficient iron stores (serum ferritin ≥ 200 ng/mL, TSAT ≥ 20%).
• Clinically stable condition for the past 4 weeks.
• Able and willing to comply with study protocol

You may not qualify if:

• Low-flux HD or temporary catheter use
• Serum albumin \< 2.5 g/dL
• Recent hospitalization (within 4 weeks)
• Scheduled kidney transplantation
• Active malignancy or infection
• Pregnancy
• Any condition impairing protocol adherence

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Far Eastern Memorial Hospital

New Taipei City, Banciao Dist., 220, Taiwan

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Restless Legs Syndrome; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Central Study Contacts

Wan-Chuan Tsai, M.D., Ph.D.

CONTACT

886-289667000; mkks618@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Laboratory technicians who assess the study outcomes will be masked
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.; Attending Physician, Division of Nephrology; Director, Clinical Trials Center; Assistant Professor, Ministry of Education

Model Details: A randomized, active-controlled trial with cross-over design

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: August 31, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2029
• Last Updated: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will become available after completing the study for 1 year and for 3 years after formal publication.
• Access Criteria: Data will be made available by the corresponding author of the paper upon request by email.

Locations

TW (1)