Post Approval Study for Treatment of Drug-resistant Adult and Pediatric Primary FSGS Using the LIPOSORBER® LA-15 System

Launched by KANEKA MEDICAL AMERICA LLC · Aug 20, 2019

Keywords

ClinConnect Summary

This clinical trial is investigating the effectiveness and safety of a device called the LIPOSORBER® LA-15 System for treating a kidney condition known as focal segmental glomerulosclerosis (FSGS) in adults and children. This condition can lead to nephrotic syndrome, which causes symptoms like swelling and high protein levels in urine. The trial focuses on patients whose standard treatments, such as steroids, have not worked well or caused severe side effects. To participate, patients should be at least 22 years old, have a certain level of kidney function, and have not responded to standard therapies for at least eight weeks.

Participants in the study can expect to undergo treatment with the LIPOSORBER® device, which aims to help improve their kidney function and health. Before joining, some individuals may be excluded due to factors like age, certain medical conditions, or the use of specific medications. It's important for potential participants to discuss their eligibility with their healthcare team and understand any risks, especially if they are pregnant or planning to become pregnant. Overall, this study seeks to provide new treatment options for patients struggling with this challenging kidney condition.

Gender

ALL

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