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New treatment option for Focal Segmental Glomerulosclerosis
Official title Post Approval Study for Treatment of Drug-resistant Adult and Pediatric Primary FSGS Using the LIPOSORBER® LA-15 System
ClinicalTrials.gov ID: NCT04065438
What this study is testing
- What it's testing
- This multicenter, prospective, single-arm clinical study will evaluate the probable benefit and safety of the LIPOSORBER® LA-15 System for the treatment of adult 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 ≥ 45 ml/min/1.73m2, or the patient has post-renal transplant recurrence. Treatment for FSGS is considered unsuccessful if the patient is unresponsive to standard therapy (e.g., at least 8 weeks of corticosteroids) and fails to achieve complete or partial remission.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 75
You may be able to join if
- 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...
- The patient is post renal transplantation.
You likely can't join if
- General Exclusion Criteria
- Patient is greater than 75 years of age at the start of the treatment period or less than 22
- The patient is unwilling or unable to sign and date the informed consent
- Pregnant, lactating, or planning to become pregnant prior to completing the study (Note: The safety of the use of LIPOSORBER® in pregnant women has...
- Unable or unwilling to comply with the follow-up schedule
- Simultaneously participating in another investigational drug or device study
See the full eligibility 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.
- General Exclusion Criteria
- Patient is greater than 75 years of age at the start of the treatment period or less than 22
- The patient is unwilling or unable to sign and date the informed consent
- 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...
- Unable or unwilling to comply with the follow-up schedule
- Simultaneously participating in another investigational drug or device study
- Body weight \< 15 kg (33.1 lbs) Medical Exclusion Criteria
- 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...
- 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
- 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
- Hypersensitivity to dextran sulfate, heparin, or ethylene oxide
- Adequate anticoagulation cannot be achieved due to severe hemophilia, severe hemorrhage diathesis, severe gastrointestinal ulcers, or are recipients of vitamin K antagonist medications
- 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...
- Cardiac impairments such as uncontrolled arrhythmia, unstable angina, decompensated congestive heart failure, or valvular disease
- Functional thyroid disease or liver abnormalities
- Unresolved systemic or local infection that could affect the clinical study outcomes
The study team makes the final eligibility decision.
Where it's taking place
- Loma Linda, California, United States
- Wilmington, Delaware, United States
- Grand Rapids, Michigan, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Akron, Ohio, United States
- Charleston, South Carolina, United States
- Richmond, Virginia, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Loma Linda, California, United States; Wilmington, Delaware, United States; Grand Rapids, Michigan, United States; New York, New York, United States; Chapel Hill, North Carolina, United States; Akron, Ohio, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.