Treatment for drug-resistant FSGS using the LIPOSORBER® LA-15 System

Treatment of Drug-resistant Adult and Pediatrc Primary Focal Segmental Glomerulosclerosis and Post -Transplant Recurrence Using the LIPOSORBER® LA-15 System

This study is testing a new treatment using the LIPOSORBER® LA-15 System to see if it can help adults with nephrotic syndrome caused by FSGS when other treatments haven't worked or can't be used.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 35 (estimated)
• Ages: N/A to 75 Years
• Sex: All
• Sponsor: Kaneka Medical America LLC (industry)
• Locations: 10 sites (Loma Linda, California and 9 other locations)
• Trial ID: NCT04065438 on ClinicalTrials.gov

What this trial studies

This multicenter, prospective, single-arm clinical study aims to evaluate the safety and efficacy of the LIPOSORBER® LA-15 System for treating adult patients with nephrotic syndrome due to primary focal segmental glomerulosclerosis (FSGS) when standard treatments have failed or are not tolerated. The study will enroll up to 35 patients across multiple clinical sites, with a treatment phase lasting approximately 9 weeks, involving a total of 12 apheresis treatments. Patients will be monitored for outcomes at various intervals post-treatment to assess the system's effectiveness.

Who should consider this trial

Good fit: Ideal candidates include adults aged 22 to 75 with nephrotic syndrome associated with primary FSGS who have not responded to standard therapies or are post-renal transplant.

Not a fit: Patients over 75 years old, those unwilling to provide consent, or those who are pregnant or lactating may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new option for patients with drug-resistant FSGS, potentially improving their kidney function and quality of life.

How similar studies have performed: While this approach is based on existing treatment modalities, the specific use of the LIPOSORBER® LA-15 System for this indication is novel and has not been extensively tested in prior studies.

Eligibility criteria

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

Where this trial is running

Loma Linda, California and 9 other locations

• Loma Linda University Children's Hospital — Loma Linda, California, United States (RECRUITING)
• Loma Linda University Hospital — Loma Linda, California, United States (RECRUITING)
• Nemours/Alfred I DuPont Hospital for Children — Wilmington, Delaware, United States (RECRUITING)
• Helen DeVos Children's Hospital — Grand Rapids, Michigan, United States (RECRUITING)
• Weill Cornell Medicine / NewYork-Presbyterian — New York, New York, United States (RECRUITING)
• University of North Carolina — Chapel Hill, North Carolina, United States (RECRUITING)
• Akron Children's Hospital — Akron, Ohio, United States (RECRUITING)
• Medical University of South Carolina Children's Hospital — Charleston, South Carolina, United States (RECRUITING)
• Medical University of South Carolina — Charleston, South Carolina, United States (RECRUITING)
• Children's Hospital of Richmond at VCU — Richmond, Virginia, United States (RECRUITING)

Study contacts

• Study coordinator: Ayaka Kitamura

Conditions: Focal Segmental Glomerulosclerosis, FSGS, Liposorber