End Stage Renal Failure, HemodialysisSHINE-RLSNCT07794826
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)
A study testing Super High-Flux HD in people with End Stage Renal Failure, Hemodialysis and Restless Leg Syndrome (RLS), run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- End Stage Renal Failure, Hemodialysis, Restless Leg Syndrome (RLS)
- What is being tested?
- Super High-Flux HD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2026to 30 Sep 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Far Eastern Memorial Hospital
New Taipei City, Banciao Dist., 220
Wan-Chuan Tsai, M.D., Ph.D., 886-277281780 ext. 1780, mkks618@gmail.com
About this study
Official title: Advancing Dialyzer Technology: Efficacy and Safety of Super High-Flux Hemodialysis in Maintenance Dialysis Patients
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.
Read the detailed description
Patients with end-stage kidney disease (ESKD) on regular high-flux hemodialysis (HD) often experience an accumulation of middle-molecule uremic toxins, which are linked to systemic inflammation and troubling symptoms such as restless legs syndrome (RLS), severe itching, and poor sleep quality. While traditional high-flux dialysis efficiently clears small molecules, its ability to remove larger middle-molecule toxins (like α1-microglobulin [α1-MG]) is limited. Current alternatives such as online hemodiafiltration (HDF) have limitations, highlighting the need for new treatment approaches. Super High-Flux Hemodialysis (SHFHD) offers enhanced clearance of these middle molecules while preserving serum albumin levels and maintaining patient safety.
In this study, the investigators evaluate the effectiveness and safety of SHFHD compared with high-flux HD in patients undergoing maintenance HD, focusing on α1-MG removal and its potential effect on RLS. The investigators also explore the multiple diverse effects of SHFHD on the changes of cardiovascular risk factors including bone turnover, mineral metabolism, vascular calcification, uremia, inflammation, immunity, metabolomics, nutrition, and gut microbial metabolites in dialysis patients.
It is to conduct a randomized, controlled, crossover trial with cross-over design at a dialysis unit of tertiary teaching hospital in Northern Taiwan. The investigators will stratify participants by baseline RLS. Participants will receive either SHFHD or high-flux HD for 12 weeks, followed by a 4-week washout and crossover. The study outcome measures are difference in change-from-baseline values of α1-MG reduction ratio, RLS severity (International Restless Legs Scale), albumin levels, clearance of β2-microglobulin, free light chains, inflammatory markers, pruritus scores, and quality of life. Safety will be assessed via albumin maintenance, adverse events, and hemodynamic stability.
This will be the first RCT directly evaluating SHFHD for α1-MG removal and RLS outcomes, addressing critical knowledge gaps and potentially informing new dialysis prescription strategies.
- Being tested
- Super High-Flux HD
- Keywords
- End-stage kidney disease, Restless leg syndrome, Super high-flux hemodialysis
- Medical subject headings
- Renal Insufficiency, Chronic, Restless Legs Syndrome, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Super High-Flux HDDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Super High-Flux HD | Experimental | Receives 12 weeks of Super High-Flux HD (Elisio™-HX) Receives: Device: Super High-Flux HD |
| High-Flux HD | No intervention | Receives 12 weeks of High-Flux HD as usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Baseline, Week 4, Week 8, and Week 12 of each 12-week treatment period
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.
Measured: Baseline, Week 4, Week 8, and Week 12 of each 12-week treatment period
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.
Measured: Baseline, Week 4, Week 8, and Week 12 of each 12-week treatment period
Change from Baseline in 5-D Itch Scale Score
Assesses pruritus severity. Evaluated as the difference in score changes between the two treatment periods.
Measured: 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
Assesses quality of life. Evaluated as the difference in score changes between the two treatment periods.
Measured: Baseline, Week 4, Week 8, and Week 12 of each 12-week treatment period
Change from Baseline in β2-microglobulin [β2-MG] Reduction ratio
The reduction ratio of β2-MG will be calculated as [({Pre-dialysis} - {Post-dialysis}) /{Pre-dialysis}] at each study visit and evaluated as the difference in the change-from-baseline reduction ratio between the Super High-Flux HD period and the High-Flux HD period.
Measured: Baseline, Week 4, Week 8, and Week 12 of each 12-week treatment period
Change from Baseline in Kappa Free Light Chains Reduction ratio
The reduction ratio will be calculated as [({Pre-dialysis} - {Post-dialysis}) /{Pre-dialysis}] at each study visit and evaluated as the difference in the change-from-baseline reduction ratio between the Super High-Flux HD period and the High-Flux HD period.
Measured: Baseline, Week 4, Week 8, and Week 12 of each 12-week treatment period
Change from Baseline in Lambda Free Light Chains Reduction ratio
The reduction ratio will be calculated as [({Pre-dialysis} - {Post-dialysis}) /{Pre-dialysis}] at each study visit and evaluated as the difference in the change-from-baseline reduction ratio between the Super High-Flux HD period and the High-Flux HD period.
Measured: Baseline, Week 4, Week 8, and Week 12 of each 12-week treatment period
Change from Baseline in Pre-dialysis Serum interleukin-6 (IL-6) Level
Measured at each study visit. Evaluated as the difference in the change from baseline between the Super High-Flux HD period and the High-Flux HD period.
Measured: Baseline, Week 4, Week 8, and Week 12 of each 12-week treatment period
Change from Baseline in Pre-dialysis Serum High-sensitivity C-reactive Protein (hs-CRP) Level
Measured at each study visit. Evaluated as the difference in the change from baseline between the Super High-Flux HD period and the High-Flux HD period.
Measured: Baseline, Week 4, Week 8, and Week 12 of each 12-week treatment period
Change from Baseline in Pre-dialysis Serum Indoxyl Sulfate Level
Measured at each study visit. Evaluated as the difference in the change from baseline between the Super High-Flux HD period and the High-Flux HD period.
Measured: Baseline, Week 4, Week 8, and Week 12 of each 12-week treatment period
Change from Baseline in Pre-dialysis Serum P-cresol Sulfate Level
Measured at each study visit. Evaluated as the difference in the change from baseline between the Super High-Flux HD period and the High-Flux HD period.
Measured: Baseline, Week 4, Week 8, and Week 12 of each 12-week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Failure, HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A randomized, active-controlled trial with cross-over design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wan-Chuan Tsai, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07794826
- Sponsor's protocol ID
- FEMH-IRB-TSAI2025
- Other IDs
- FEMH-IIT-2026-01
- Acronym
- SHINE-RLS
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual-level deidentified participant data will be made available by the corresponding author of the paper upon request by email. The data will be available for 3 years after formal publication.