Treatment of Adult and Pediatric FSGS Using the LIPOSORBER LA-15 System

What is the Purpose of this Study?

This study focuses on adults and children who have primary focal segmental glomerulosclerosis (FSGS- a disease of the kidney that causes large losses of protein in the urine) and whose kidney problems have remained despite receiving medications or a kidney transplant. The purpose of the study is to evaluate a device called the LIPOSORBER LA-15 System in relieving kidney problems associated with primary FSGS or post-transplant recurrence. The system consists of three parts that are used once and thrown away (disposables), in addition to a machine that controls and checks the system’s mechanical function while the patient undergoes the procedure.

The device takes out some of the patient’s blood, cleans it, and then lets the cleaned blood return to the body, which may ease illness. Since FSGS may prevent the kidneys from working, researchers aim to determine whether this treatment can help improve kidney function.

Eligibility

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.

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:

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)
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

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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

Treatment of Drug-resistant Adult and Pediatric Primary Focal Segmental Glomerulosclerosis Using the LIPOSORBER® LA-15 System

Study Details

Disease Type/Condition

Other

Principal Investigator

Karumanchi, Subbian

Co-Investigators

Edmund Huang, Ellen Klapper, Sanjeev Kumar, Stanley Jordan

Age Group

Adult

Phase

N/A

IRB Number

STUDY00000613

ClinicalTrials.gov ID

NCT04065438

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org