NCT07794826Not yet recruiting
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)
Advancing Dialyzer Technology: Efficacy and Safety of Super High-Flux Hemodialysis in Maintenance Dialysis Patients
Source: ClinicalTrials.gov · Last updated 31 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 27 Aug 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Far Eastern Memorial Hospital
- Diseases
- Chronic kidney disease
- NCT number
- NCT07794826
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 1 Oct 2026 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Scheduled kidney transplantation
Other illness
- Active malignancy or infection
- Any condition impairing protocol adherence
Lab values
- Serum albumin \< 2.5 g/dL
Other
- Low-flux HD or temporary catheter use
- Recent hospitalization (within 4 weeks)
- Pregnancy
Who the study is looking for
- 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
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Far Eastern Memorial Hospital Coordinator of this site? Confirm its status | New Taipei City | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.