Can a blood filter calm a kidney disease that drugs Can't?
NCT ID NCT04065438
First seen Aug 28, 2026 · Last updated Aug 28, 2026
Summary
This trial tests whether a blood purification device called LIPOSORBER LA-15 can help people with focal segmental glomerulosclerosis (FSGS), a kidney disease that causes protein to leak into the urine. The study includes adults whose disease did not respond to standard treatments like corticosteroids or calcineurin inhibitors, and people who had a kidney transplant and saw the disease return. Participants receive a series of blood filtration sessions, and researchers measure changes in urine protein levels and overall kidney function over several months to see if the treatment is safe and beneficial.
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, a blood purification device that filters out LDL and other apoprotein B-containing lipoproteins from the blood
- What this could lead to
- If it works, this blood-filtering approach could offer a new option for people 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
- This is an early, single-arm study with a small number of participants, so results may not apply broadly. The treatment involves blood filtration, which carries risks like bleeding, infection, or drops in blood pressure, and it may not achieve lasting remission.
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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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Jan 2020
- 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 75 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 patient is deemed suitable for inclusion in the study if the patient has nephrotic syndrome associated with primary FSGS when: • Standard treatment options, including corticosteroid and/or calcineurin inhibitors, are unsuccessful or not well tolerated and the patient's glomerular filtration rate (GFR) ≥ 45 ml/min/1.73 m2. or • The patient is post renal transplantation. Exclusion Criteria: General Exclusion Criteria 1. Patient is greater than 75 years of age at the start of the treatment period or less than 22 2. The patient is unwilling or unable to sign and date the informed consent 3. 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 childbearing potential should avoid pregnancy during the use of the LIPOSORBER device and throughout the study duration.) 4. Unable or unwilling to comply with the follow-up schedule 5. Simultaneously participating in another investigational drug or device study 6. Body weight \< 15 kg (33.1 lbs) Medical Exclusion Criteria 1. 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.) 2. Currently being administered antihypertensive drugs other than ACE inhibitors (e.g., ARBs) that cannot be withheld on the day of apheresis until after the procedure 3. 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 4. Hypersensitivity to dextran sulfate, heparin, or ethylene oxide 5. Adequate anticoagulation cannot be achieved due to severe hemophilia, severe hemorrhage diathesis, severe gastrointestinal ulcers, or are recipients of vitamin K antagonist medications 6. 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 Note: Severe uncontrollable hypotension/hypertension indicates the cases with systolic and/or diastolic blood pressure ≤ 5th percentile for age, gender, and height. 7. Cardiac impairments such as uncontrolled arrhythmia, unstable angina, decompensated congestive heart failure, or valvular disease 8. Functional thyroid disease or liver abnormalities 9. 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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Children's Hospital of Richmond at VCU
RECRUITINGRichmond, Virginia, 23298, 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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Loma Linda University Hospital
RECRUITINGLoma Linda, California, 92354, United States
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Medical University of South Carolina
RECRUITINGCharleston, South Carolina, 29425, 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/Alfred I DuPont Hospital for Children
RECRUITINGWilmington, Delaware, 19803, United States
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University of North Carolina
RECRUITINGChapel Hill, North Carolina, 27599, United States
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Weill Cornell Medicine / NewYork-Presbyterian
RECRUITINGNew York, New York, 10065, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a blood filter turn the tide on Drug-Resistant kidney disease in children?
- Kidney disease mystery: scientists launch massive data hunt
- Scientists hunt for genes behind kidney disease
- 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