Post Approval Study of Liposorber LA-15 System for the Treatment of Focal Segmental Glomerulosclerosis in Children

  • STATUS
    Recruiting
  • End date
    Oct 7, 2024
  • participants needed
    35
  • sponsor
    Kaneka Medical America LLC
Updated on 7 May 2021
corticosteroids
remission
kidney transplant
low density lipoprotein
proteinuria
alternative therapies
plasma cholesterol
nephrotic syndrome
primary focal segmental glomerulosclerosis
focal segmental glomerulosclerosis

Summary

Liposorber LA-15 System is a blood purification therapy that selectively removes malignant lipoproteins including low density lipoprotein from circulating blood flow and rapidly reduces the plasma cholesterol level. The system was originally developed for the treatment of patients with serious dyslipidemia such as familial hypercholesterolemia and then applied to improve the dyslipidemia, a common complication of nephrotic syndrome and found to bring about improvement not only with the dyslipidemic condition but the nephrotic condition (e.g, proteinuria and hypoproteinemia).

Although the definitive mechanism by which the system may relieve nephrotic syndrome is unknown, it has been recognized as one of alternative therapies for refractory nephrotic syndrome including focal segmental glomerulosclerosis (FSGS) in Japan and referred in the Guidelines for the Treatment of Nephrotic Syndrome endorsed by The Japanese Society of Nephrology.

This study is conducted as a post approval study imposed by Humanitarian Device Exemption (HDE) order to confirm the safety and efficacy of the Liposorber LA-15 System in the treatment of drug-resistant pediatric primary FSGS.

Details
Condition Focal glomerulosclerosis, Glomerulonephritis, Focal Segmental Glomerulosclerosis 1, Focal Segmental Glomerulosclerosis
Treatment Liposorber® LA-15 System
Clinical Study IdentifierNCT02235857
SponsorKaneka Medical America LLC
Last Modified on7 May 2021

Eligibility

Yes No Not Sure

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 arrhythmia, 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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