Can a blood filter turn the tide on Drug-Resistant kidney disease in children?

NCT ID NCT02235857

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 28, 2026 · Last updated Aug 28, 2026

Summary

This trial tests whether a blood purification device called the Liposorber LA-15 System can help children with focal segmental glomerulosclerosis (FSGS), a kidney disease that causes protein to leak into the urine and often resists standard treatments. The device filters the blood to remove certain fats and proteins, which may also ease the kidney condition. Researchers will measure how many children achieve complete or partial remission, and they will track any serious side effects related to the device or procedure.

What this could mean

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

Active substance
Liposorber LA-15 System, a blood purification device that filters out certain fats and proteins from the blood
What this could lead to
If it works, this blood-filtering therapy could offer a new option for children with focal segmental glomerulosclerosis who do not respond to standard drugs, potentially reducing protein in the urine and easing kidney damage.
What could go wrong
The trial is small and early, and the exact way the device helps kidney disease is not fully understood. It may not work for all children, and the treatment involves a blood-filtering procedure that carries risks like infection or bleeding.

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 35 people

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

Started

May 2015

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

Up to 21 years

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: * A pediatric patient is deemed suitable for inclusion in the study if the patient has FSGS with a GFR ≥ 45 ml/min/1.73 m 2 and any of the following: * Refractory nephrotic syndrome in which standard treatment options are unsuccessful (i.e., patient is unresponsive to standard corticosteroid and/or calcineurin inhibitor therapy for at least 8 weeks resulting in failure to achieve complete or partial remission); * Refractory nephrotic syndrome in which standard treatment options are not well tolerated (i.e., patients intolerant to standard therapies due to severe side effects that negatively affect quality of life without providing an acceptable level of clinical benefit); * Refractory or recurrent nephrotic syndrome in which standard therapy is contraindicated. or \- Pediatric post renal transplant patients with nephrotic syndrome associated with primary FSGS. Exclusion Criteria: * General Exclusion Criteria * Patient is greater than 21 years of age * Parent or patient is unwilling or unable to sign and date the informed consent (Note: Only patients 18-21 years of age may sign the informed consent on their own behalf) * Pregnant, lactating, or planning to become pregnant prior to completing the study (Note: The safety of the use of Liposorber® in pregnant women has not been studied. There may be unknown risks to an embryo/fetus. Sexually active women of child bearing potential should avoid pregnancy during the use of the Liposorber device and throughout the study duration.) * Unable or unwilling to comply with the follow-up schedule * Simultaneously participating in another investigational drug or device study * Body weight \< 15 kg (33.1 lbs) * Medical Exclusion Criteria * Currently being administered ACE inhibitors that cannot be withheld for at least 24 hours prior to each apheresis treatment (Note: The time period to withhold ACE inhibitors should be prolonged, if determined by the treating physician, considering each individual's renal function and the biological half-life of the ACE-inhibitor currently in use.) * Currently being administered antihypertensive drugs other than ACE inhibitors (e.g., Angiotensin II receptor blockers (ARBs) that cannot be withheld on the day of apheresis until after the procedure * Medical condition or disorder that would limit life expectancy to less than the primary clinical study endpoint or that may cause noncompliance with the study plan or confound the data analysis * Hypersensitivity to dextran sulfate, heparin, or ethylene oxide * Adequate anticoagulation cannot be achieved due to severe hemophilia, severe hemorrhage diathesis, severe gastrointestinal ulcers, or are recipients of vitamin K antagonist medications * Extracorporeal circulation therapy with Liposorber® LA-15 System cannot be tolerated due to severe cardiac insufficiency, acute myocardial infarction, severe cardiac arrhythmia, acute apoplexy, severe uncontrollable hypertension, or severe uncontrollable hypotension * Cardiac impairments such as uncontrolled arrhyth¬mia, unstable angina, decompensated congestive heart failure, or valvular disease * Functional thyroid disease or liver abnormalities * Unresolved systemic or local infection that could affect the clinical study outcomes

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Focal segmental glomerulosclerosis are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    10 sites. 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

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Akron Children's Hospital

    RECRUITING

    Akron, Ohio, 44308, United States

  • Cedars Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Children's Hospital of Richmond at VCU

    WITHDRAWN

    Richmond, Virginia, 23219, United States

  • Helen DeVos Children's Hospital

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Loma Linda University Children's Hospital

    RECRUITING

    Loma Linda, California, 92354, United States

  • Medical University of South Carolina Children's Hospital

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Nemours Children's Health

    TERMINATED

    Orlando, Florida, 32827, United States

  • Nemours/A.I. duPont Hospital for Children

    RECRUITING

    Wilmington, Delaware, 19803, United States

  • St. Christopher's Hospital for Children

    RECRUITING

    Philadelphia, Pennsylvania, 19134, United States

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55454, United States

  • University of North Carolina

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • Weill Cornell Medical Center / NewYork-Presbyterian

    RECRUITING

    New York, New York, 10065, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.