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A new dialyzer may clear more toxins and calm restless legs

NCT ID NCT07794826

Symptom relief Sponsor: Far Eastern Memorial Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This trial tests whether a super high-flux dialyzer, a more efficient filter used during hemodialysis, can remove more middle-molecule toxins from the blood than standard high-flux dialyzers. The study includes 40 adults with end-stage kidney disease who are on maintenance dialysis and also have restless legs syndrome. Over 12 weeks, researchers will measure changes in toxin levels and restless legs symptoms, comparing the super high-flux period with the standard period. The goal is to see if better toxin removal can ease symptoms like restless legs, itching, and poor sleep.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Super high-flux dialyzer (Type V high-performance dialyzer, e.g., Elisio-HX or Theranova) used during hemodialysis
What this could lead to
If it works, this could point toward a way to ease restless legs syndrome and related symptoms in people on long-term dialysis, improving their quality of life.
What could go wrong
This is a small, early-stage trial with 40 participants, so results may not apply broadly. The new dialyzer might not remove enough toxins to make a difference, and any device carries risks like clotting or allergic reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Diagnosis of Restless Legs Syndrome according to standard criteria. 2. Age ≥ 20 years. 3. Maintenance high-flux hemodialysis for ≥ 3 months. 4. Stable vascular access (AV fistula or AV graft). 5. Adequate dialysis delivery (URR ≥ 65% or Kt/V(daugirdes) ≥ 1.2). 6. Sufficient iron stores (serum ferritin ≥ 200 ng/mL, TSAT ≥ 20%). 7. Clinically stable condition for the past 4 weeks. 8. Able and willing to comply with study protocol Exclusion Criteria: 1. Low-flux HD or temporary catheter use 2. Serum albumin \< 2.5 g/dL 3. Recent hospitalization (within 4 weeks) 4. Scheduled kidney transplantation 5. Active malignancy or infection 6. Pregnancy 7. Any condition impairing protocol adherence

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome end stage renal failure restless legs syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

End stage renal failure, hemodialysis Restless leg syndrome (RLS)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Far Eastern Memorial Hospital

    New Taipei City, Banciao Dist., 220, Taiwan

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