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| General |
| Study Status |
Delayed |
Application Number /
Requirement Number |
H170002 / PAS001 |
| Date Original Protocol Accepted |
03/04/2019
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| Date Current Protocol Accepted |
08/26/2026
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| Study Name |
New Enroll PAS LIPOSORBER LA-15 Adults
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| Device Name |
LIPOSORBER LA-15 System
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Infant: 29 days < 2 yrs,
Child: 2 yrs < 12 yrs,
Adolescent: 13-18 yrs,
Transit.Adolescent A (distinctively):18 yrs<22 yrs,
Transit.Adolescent B(as adults): 18 yrs < 22 yrs,
Adult: At least 22 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
Design: multicenter, prospective, single-arm, new enrollment clinical study to evaluate the probable benefit and safety of the LIPOSORBER® LA-15 System
Objectives:
The primary objectives of this study are to evaluate the safety and probable benefit of the LIPOSORBER® LA-15 System in relieving nephrotic syndrome associated with primary FSGS at 1 month after the final apheresis treatment.
The secondary objectives are to evaluate safety and probable benefit of the LIPOSORBER® LA-15 System in relieving nephrotic syndrome associated with primary FSGS at 3 months, 6 months, 12 months, and 24 months after the final apheresis treatment.
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| Study Population |
Inclusion Criteria
Adult and pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis (FSGS), when the standard treatment options, including corticosteroid and/or calcineurin inhibitors treatments, have been unsuccessful or not well tolerated, and the patient has a glomerular filtration rate (GFR) greater than or equal to 45 ml/min/1.73m2, or the patient is post-renal transplantation.
Exclusion Criteria
General Exclusion Criteria:
1. Older than 75 years of age in the Adult Study or older than 21 years in the Pediatric Study
2. Parent or 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
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.
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 after surgery
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
7. Cardiac impairments such as uncontrolled arrhythmia, unstable angina, decompensated congestive heart failure, or valvular disease intolerant to apheresis treatment
8. Ongoing diagnosis of Functional thyroid disease other than hypothyroidism due to nephrotic syndrome or Hashimoto's thyroiditis, or liver abnormalities
9. Unresolved systemic or local infection (e.g., Catheter infections or urinary tract infections) that could affect the clinical study outcomes
10. Patients without a history of biopsy-proven FSGS diagnosis
11. Currently receiving or have received treatment with LIPOSORBER® LA-15 System
12. Patients who require any plasmapheresis other than LIPOSORBER® LA-15 System and are unable to discontinue prior to pre-screening, or who are planning to have any plasmapheresis other than LIPOSORBER® LA-15 System
13. Currently undergoing hemodialysis
14. Ongoing diagnosis of End Stage Renal Disease (ESRD)
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| Sample Size |
35 pediatric patients and 35 adult patients (total of 70 patients)
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| Key Study Endpoints |
The primary probable benefit endpoint is the percent of patients who show complete or partial remission at 1 month after the final apheresis treatment.
- The primary safety endpoint is the rate of device-related and procedure-related serious adverse events (SAEs) occurring during the treatment period and up to 1-month follow-up visit.
- The secondary objectives are:
o to evaluate safety and probable benefit of the LIPOSORBER® LA-15 System in relieving nephrotic syndrome associated with refractory primary FSGS at 3 months, 6 months, 12 months, and 24 months after the final apheresis treatment.
o The secondary safety and probable benefit endpoints include nephrotic condition (complete remission, partial remission, and nephrotic state) including the percentage of patients who obtain complete and partial remission at 3, 6, 12, and 24 months;
o incidence of adverse events encountered during the period in which apheresis treatments are given;
o incidence of all adverse events and SAEs occurring within 3, 6, 12, and 24 months after the final apheresis treatment; and
o laboratory values, including eGFR at baseline, after the last treatment, and at 1, 3, 6, 12, and 24 months after the final apheresis treatment, including percent change from baseline and percentage of patients showing an increase or decrease in each value.
The data will be analyzed and presented separately for the pediatric and adult populations.
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| Follow-up Visits and Length of Follow-up |
24 months after the final apheresis treatment.
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| Interim or Final Data Summary |
| Interim Results |
Safety:
Among adult patients, there were zero AEs and zero SAE
during this reporting period. Among pediatric patients, there
were 6 new SAEs that occurred in 1 patient: worsening edema,
worsening ascites, respiratory distress, sepsis, AKI, and a
second occurrence of worsening edema. All events were
deemed not related to the Liposorber treatment.
Effectiveness:
The proportion of pediatric patients in complete or partial remission
ranged from 53% (8/15) at 1 month follow-up to 83% (5/6) at 24
months follow-up. The proportion of adult patients in complete or
partial remission ranged from 27% (3/11) at 1 month follow-up to
33% (1/3) at 24 months. The small number of pediatric and adult
patients, particularly at the later follow-up visits, make it difficult to
get a stable estimate of device effectiveness at this time.
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| Actual Number of Patients Enrolled |
29 pediatric and 19 adult enrollments
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| Actual Number of Sites Enrolled |
17 sites
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| Patient Follow-up Rate |
Pediatric: 83% (15/18) at 1 month, 67% (12/18) at 3 months, 56%
(10/18) at 6 months, 56% (10/18) at 12 months, and 33% (6/18) at
24 months.
Adults: 92% (11/12) at 1 month, 67% (8/12) at 3 months, 58%
(7/12) at 6 months, 33% (4/12) at 12 months, and 25% (3/12) at 24
months.
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