Post Approval Study for Treatment of Drug-resistant Adult Primary FSGS Using the LIPOSORBER LA-15 System

  • STATUS
    Recruiting
  • End date
    Jun 1, 2025
  • participants needed
    35
  • sponsor
    Kaneka Medical America LLC
Updated on 5 May 2021
corticosteroids
remission
kidney transplant
glomerular filtration rate
proteinuria
calcineurin inhibitors
plasma cholesterol
nephrotic syndrome
primary focal segmental glomerulosclerosis
focal segmental glomerulosclerosis

Summary

This multicenter, prospective, single-arm clinical study will evaluate the probable benefit and safety of the LIPOSORBER LA-15 System for the treatment of adult patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis, when the standard treatment options, including corticosteroid and/or calcineurin inhibitors treatments, have been unsuccessful or not well tolerated, and the patient has a GFR 45 ml/min/1.73m2, or the patient has post-renal transplant recurrence. Treatment for FSGS is considered unsuccessful if the patient is unresponsive to standard therapy (e.g., at least 8 weeks of corticosteroids) and fails to achieve complete or partial remission. A standard treatment is considered not well tolerated if the patient experiences severe side effects without providing an acceptable level of clinical benefit.

Description

This study will enroll up to 35 adult patients at 3-10 clinical sites. The duration of the treatment phase of the study will take approximately 9 weeks for a total of 12 apheresis treatments with the LIPOSORBER LA-15 System; the treatments will be given twice weekly for 3 weeks followed by once weekly for 6 weeks. Patients will undergo follow-up at 1, 3, 6, 12, and 24 months after the final apheresis treatment.

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 primary FSGS and post Transplant recurrence.

Details
Condition Focal glomerulosclerosis, Glomerulonephritis, Focal Segmental Glomerulosclerosis
Treatment LIPOSORBER® LA-15
Clinical Study IdentifierNCT04065438
SponsorKaneka Medical America LLC
Last Modified on5 May 2021

Eligibility

Yes No Not Sure

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
Patient is greater than 75 years of age at the start of the treatment period or less than 22
The patient is unwilling or unable to sign and date the informed consent
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.)
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., 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 Note: Severe uncontrollable hypotension/hypertension indicates the cases with systolic and/or diastolic blood pressure 5th percentile for age, gender, and height
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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