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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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New Enroll PAS LIPOSORBER LA-15 Adults


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General
Study Status Study Pending
Application Number H170002 / PAS001
Date Current Protocol Accepted 03/04/2019
Study Name New Enroll PAS LIPOSORBER LA-15 Adults
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Infant: 29 days-2 yrs, Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description 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.
Study Population Description Adult and pediatric 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 greater than or equal to 60 ml/min/1.73m2, or the patient is post renal transplantation. No comparator group is included.

Inclusion Criteria:

Patient eligibility for enrollment shall be based on known information at the time of the procedure. Patients will be selected in accordance with the Manufacturer’s Instructions for Use, the Operator’s Manual and this study protocol. Information obtained at a later date may contradict these criteria, but this will not be considered a violation of the study plan. 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) greater than or equal to 60 ml/min/1.73 m2. or The patient is post renal transplantation. Exclusion Criteria A patient is excluded from enrollment into the study if any of the following are true:

General Exclusion Criteria 1. Patient is greater than 75 years of age at the start of the treatment period 2. Parent or patient is unwilling or unable to sign and date the informed consent (Note: Patients 18 years of age or older sign the informed consent on their own behalf) 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 child bearing 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 < 18 kg (39.7 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 less than or equal to 5th percentile for age, gender, and height. Cardiac impairments such as uncontrolled arrhythmia, unstable angina, decompensated congestive heart failure, or valvular disease 2. Thyroid disease or liver abnormalities 3. Unresolved systemic or local infection that could affect the clinical study outcomes
Sample Size 35 adults and 35 children at 3 to 10 clinical sites. Sample size was calculated considering both the primary safety and the primary probable benefit objectives.

The primary probable benefit endpoint will be assessed using a 95% confidence interval. The assumption for sample size calculation was that 50% of patients would achieve a 50% reduction in urine protein at 1 month. Optimal conservative medical therapy would be expected to be approximately 10% based on the collected data in Glomerular Disease Collaborative Network (University of North Carolina, Chapel Hill, NC) as stated in the FONT study protocol which include both adults and pediatrics (age 1 to 51 years at time of randomization).11 The reported clinical results in steroid-resistant FSGS treated with the LIPOSORBER® LA-15 System suggest the incidence of favorable cases is at least 25%, implying that the probable benefit of the system is superior to that of ordinary medical therapies. With a performance goal of 25%, an expected rate of 50% of patients, a one-sided exact binomial test, and a type I error rate of 0.025 (corresponding to a 95% one-sided confidence interval), 30 patients provides a power of 0.82.

The primary safety endpoint will be assessed using a 95% confidence interval. An incidence rate of serious device-related and procedure-related adverse events of less than or equal to 10% is considered clinically acceptable in both adults and pediatrics. The rate of device-related and procedure-related SAE during the 9-week treatment period for patients receiving LIPOSORBER® apheresis treatments up to including the first follow-up visit after the last treatment was assumed to be 3%; the error rate for the confidence interval was set to be 7% resulting in a hypothesized upper bound of 10%. With a type I error of 0.025, corresponding to a 95% one-sided confidence interval, the enrollment of 11 patients, each having 12 procedures, is required.

Thus, the primary probable benefit requires the largest sample size (n = 30). To account for patient attrition and loss to follow-up, 35 each of adult and pediatric patients will be enrolled.
Data Collection Primary 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 period in which the apheresis procedures are administered and up to at the 1-month follow-up visit.

Secondary Endpoints

The secondary endpoints will be to measure the following:

Nephrotic condition (complete remission, partial remission, and nephrotic state) at 1, 3, 6, 12, and 24 months after the final apheresis treatment, including the percentage of patients who obtain complete or partial remission at 3, 6, 12, and 24 months

Incidence of adverse events encountered during the period in which apheresis treatments are given

Incidence of all AEs and SAEs occurring within 3, 6, 12, and 24 months after the final apheresis treatment

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
Follow-up Visits and Length of Follow-up 1, 3, 6, 12, and 24 months after the final apheresis treatment.


New Enroll PAS LIPOSORBER LA-15 Adults Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 09/18/2018 09/10/2018 On Time
one year report 03/20/2019 03/15/2019 On Time
18 month report 09/18/2019    
two year report 03/19/2020    
three year report 03/19/2021    
four year report 03/19/2022    
five year report 03/18/2023    
six year report 03/18/2024    
seven year report 03/18/2025    
final report 09/01/2025    
eight year report 03/18/2026    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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