Study of LIPOSORBER® LA-15 System for Childhood FSGS
This study is looking at the LIPOSORBER® LA-15 System, a blood purification treatment, for children up to 21 years old with Focal Segmental Glomerulosclerosis (FSGS). FSGS is a kidney disease that can lead to kidney failure. The LIPOSORBER® LA-15 System works by removing certain fats from the blood. You may be able to join if you have FSGS, your kidneys are working well enough (GFR ≥ 45 ml/min/1.73 m2), and standard treatments haven't worked. The study will measure if patients show complete or partial improvement in their condition after treatment, and will also track any serious side effects. The current status of this study is unclear.
- Study design
- This is an interventional study planning to enroll 35 participants. It is not specified if it is randomized or blinded.
- What's involved
- Participants will receive LIPOSORBER® LA-15 System treatments twice weekly for 3 weeks, then once weekly for 6 weeks, for a total of 9 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for serious adverse events during treatment and up to one month after the final treatment.
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NCT02235857
Post Approval Study of Liposorber LA-15 System for the Treatment of Focal Segmental Glomerulosclerosis in Children
Recruiting
NAUp to 21InterventionalTreatmentKaneka Medical America LLC
~35 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:LIPOSORBER® LA-15 System
At a glance
Recruiting sites
10 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The percent of patients who show complete or partial remission
Measured over 1 month after the final treatment
+1 more outcome measured
Conditions
Where it's being run
12 sites across 11 statesCalifornia2
Delaware1
Florida1
Michigan1
Minnesota1
New York1
North Carolina1
Ohio1
Study leadership
- Jeffrey I Silberzweig, MD · PRINCIPAL_INVESTIGATOR · Weill Medical College of Cornell University
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
Exclusion
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)
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
What this trial measures
- The percent of patients who show complete or partial remission1 month after the final treatment
- the rate of device-related and procedure-related serious adverse eventsDuring the period in which the apheresis procedures are administered and up to at the 1-month follow-up visit