Can a blood filter turn the tide on Drug-Resistant kidney disease in children?
NCT ID NCT02235857
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 35 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2015
- Expected to finish
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Sep 2029
An estimate. End dates often move.
- Lead sponsor
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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
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Up to 21 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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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.
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The places running it
10 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Akron Children's Hospital
RECRUITINGAkron, Ohio, 44308, United States
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Cedars Sinai Medical Center
RECRUITINGLos Angeles, California, 90048, United States
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Children's Hospital of Richmond at VCU
WITHDRAWNRichmond, Virginia, 23219, United States
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Helen DeVos Children's Hospital
RECRUITINGGrand Rapids, Michigan, 49503, United States
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Loma Linda University Children's Hospital
RECRUITINGLoma Linda, California, 92354, United States
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Medical University of South Carolina Children's Hospital
RECRUITINGCharleston, South Carolina, 29425, United States
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Nemours Children's Health
TERMINATEDOrlando, Florida, 32827, United States
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Nemours/A.I. duPont Hospital for Children
RECRUITINGWilmington, Delaware, 19803, United States
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St. Christopher's Hospital for Children
RECRUITINGPhiladelphia, Pennsylvania, 19134, United States
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University of Minnesota
RECRUITINGMinneapolis, Minnesota, 55454, United States
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University of North Carolina
RECRUITINGChapel Hill, North Carolina, 27599, United States
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Weill Cornell Medical Center / NewYork-Presbyterian
RECRUITINGNew York, New York, 10065, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New drug aims to plug kidney leaks in multiple diseases
- New pill aims to plug protein leak in kidney patients
- New biobank aims to unlock why kidney disease returns after transplant