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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 March 2025
• Main ID: NCT02235857
• Date of registration: 06/09/2014
• Prospective Registration: Yes
• Primary sponsor: Kaneka Medical America LLC
• Public title: Post Approval Study of Liposorber LA-15 System for the Treatment of Focal Segmental Glomerulosclerosis in Children FSGS pediatric
• Scientific title: Treatment of Drug-resistant Pediatric Primary Focal Segmental Glomerulosclerosis Using the Liposorber® LA-15 System
• Date of first enrolment: May 3, 2015
• Target sample size: 35
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02235857
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Ayaka Kitamura

• Name: Jeffrey I Silberzweig, MD
• Affiliation: Weill Medical College of Cornell University

Key inclusion & exclusion criteria

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


Age minimum: N/A
Age maximum: 21 Years
Gender: All

Health Condition(s) or Problem(s) studied

Focal Segmental Glomerulosclerosis

Intervention(s)

Device: LIPOSORBER® LA-15 System

Primary Outcome(s)

the rate of device-related and procedure-related serious adverse events [Time Frame: During the period in which the apheresis procedures are administered and up to at the 1-month follow-up visit]

The percent of patients who show complete or partial remission [Time Frame: 1 month after the final treatment]

Secondary Outcome(s)

Incidence of adverse events and severe adverse events [Time Frame: From 1 months to 24 months after the final aphresis]

Nephrotic Condition [Time Frame: 1, 3, 6, 12, and 24 months after the final treatment]

Incidence of adverse events [Time Frame: From the initiation of the first apheresis session until the termination of the last (usually 12th) apheresis session, standad period of 9 weeks for a total of 12 aoheresis sessions]

Various laboratory values [Time Frame: 1,3, 6, 12, and 24 months after the final apheresis]

The percent of patients who obtain complete or partial remission [Time Frame: 3, 6, 12, and 24 months after the final treatment]

Secondary ID(s)

KMA-FSGS-H120005

Source(s) of Monetary Support

Please refer to primary and secondary sponsors