What side effects are associated with this type of intervention?

Common treatments for Focal Segmental Glomerulosclerosis (FSGS) include corticosteroids, calcineurin inhibitors, and lipid apheresis systems like the LIPOSORBER® LA-15. Corticosteroids can cause side effects such as weight gain, hypertension, diabetes, and increased risk of infections. Calcineurin inhibitors may lead to nephrotoxicity, hypertension, and hyperglycemia. Lipid apheresis systems, which remove lipoproteins and immune complexes from the blood, can cause side effects including hypotension, dizziness, and potential allergic reactions. These treatments aim to reduce proteinuria and preserve kidney function but come with varying degrees of risk and side effects.

What prior FDA approvals exist?

The LIPOSORBER® LA-15 System is a lipid apheresis system approved for treating nephrotic syndrome associated with primary FSGS, particularly when standard treatments such as corticosteroids and calcineurin inhibitors are ineffective or poorly tolerated. This system works by removing lipoproteins and immune complexes from the blood, aiming to reduce proteinuria and improve kidney function. Other FDA-approved treatments for FSGS primarily include immunosuppressive therapies like corticosteroids and calcineurin inhibitors, but lipid apheresis represents a more targeted approach for patients with drug-resistant forms of the disease.

What other types of research exist?

Promising alternatives to the LIPOSORBER® LA-15 System for FSGS patients include plasmapheresis, which has been used effectively in various conditions such as familial hypercholesterolemia and cryoglobulinemia. Additionally, the Molecular Adsorbent Recirculating System (MARS) has shown effectiveness in other conditions and may be considered for FSGS. These treatments have demonstrated the ability to remove harmful substances from the blood and improve clinical symptoms.

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Extracorporeal Blood Treatment

LIPOSORBER® LA-15 System for Focal Segmental Glomerulosclerosis (FSGSALLAGE Trial)

Q: What is the mechanism of action of this treatment?

The most common treatments for Focal Segmental Glomerulosclerosis (FSGS) include corticosteroids, calcineurin inhibitors, and lipid apheresis systems like the LIPOSORBER® LA-15. Corticosteroids work by reducing inflammation and suppressing the immune system, which helps to decrease proteinuria and preserve kidney function. Calcineurin inhibitors also suppress the immune system but specifically target T-cell activation, reducing the immune response that contributes to kidney damage. The LIPOSORBER® LA-15 system removes lipoproteins and immune complexes from the blood, which can help reduce the levels of circulating factors that contribute to kidney injury. These treatments are crucial for FSGS patients as they aim to reduce proteinuria, slow disease progression, and improve overall kidney function, thereby enhancing the patient's quality of life and long-term prognosis.

N/A

Recruiting

Research Sponsored by Kaneka Medical America LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A patient has nephrotic syndrome associated with primary FSGS when standard treatment options are unsuccessful or not well tolerated and the patient's glomerular filtration rate (GFR) ≥ 45 ml/min/1.73 m2

A patient is post renal transplantation

Must not have

Cardiac impairments such as uncontrolled arrhythmia, unstable angina, decompensated congestive heart failure, or valvular disease

Body weight < 15 kg (33.1 lbs)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month after the final apheresis treatment.

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a blood-filtering device called the LIPOSORBER® LA-15 System in adults with kidney issues from FSGS who haven't had success with other treatments or have had severe side effects. The device helps by cleaning the blood to protect the kidneys.

Who is the study for?

This trial is for adults and children with a kidney disease called primary FSGS who haven't improved on standard treatments or can't handle their side effects. Participants need to have a certain level of kidney function (GFR ≥ 45 ml/min/1.73m2) and can be post-kidney transplant patients. It's not for those over 75, under 22, with severe health issues that could affect the study, or women who are pregnant.

What is being tested?

The LIPOSORBER® LA-15 System is being tested in this study. It's designed for people whose focal segmental glomerulosclerosis hasn't responded to usual treatments like steroids or calcineurin inhibitors, or if these treatments caused severe side effects.

What are the potential side effects?

Possible side effects of using the LIPOSORBER® LA-15 System may include reactions related to blood filtering process such as low blood pressure, bleeding due to heparin (a drug used during the procedure), allergic reactions to materials used in the device like dextran sulfate, and complications from having tubes placed in the body.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have FSGS with unsuccessful standard treatments and my kidney function is still okay.

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I have had a kidney transplant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have serious heart problems like uncontrolled irregular heartbeat or severe heart failure.

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My body weight is less than 33.1 lbs.

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I am taking blood pressure medicine that isn't an ACE inhibitor and can't stop it for apheresis.

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I am unable or unwilling to sign the consent form.

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I cannot undergo LIPOSORBER® treatment due to severe heart or blood pressure issues.

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I cannot take blood thinners due to severe bleeding disorders or stomach ulcers.

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I do not have any ongoing infections that could interfere with the study.

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I cannot or do not want to follow the study's visit schedule.

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I am either over 75 or under 22 years old.

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I have thyroid or liver problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month after the final apheresis treatment.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month after the final apheresis treatment.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month after the final apheresis treatment. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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. partial remission at 1 month after the final apheresis treatment.

Secondary study objectives

Nephrotic condition 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.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: LIPOSORBER® LA-15 SystemExperimental Treatment1 Intervention

All study patients who meet the study eligibility criteria will undergo the extracorporeal treatment using LIPOSORBER® LA-15 System. The participants are to be treated with the system twice weekly for the 3weeks and then once weekly for the following 6 weeks.

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Focal Segmental Glomerulosclerosis (FSGS) include corticosteroids, calcineurin inhibitors, and lipid apheresis systems like the LIPOSORBER® LA-15. Corticosteroids work by reducing inflammation and suppressing the immune system, which helps to decrease proteinuria and preserve kidney function. Calcineurin inhibitors also suppress the immune system but specifically target T-cell activation, reducing the immune response that contributes to kidney damage. The LIPOSORBER® LA-15 system removes lipoproteins and immune complexes from the blood, which can help reduce the levels of circulating factors that contribute to kidney injury. These treatments are crucial for FSGS patients as they aim to reduce proteinuria, slow disease progression, and improve overall kidney function, thereby enhancing the patient's quality of life and long-term prognosis.

[Case of a focal segmental glomerulosclerosis collapsing variant associated with a hypertrophic column of Bertin].