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Blood Purification Therapy

Liposorber LA-15 Therapy for Focal Segmental Glomerulosclerosis (FSGS pediatric Trial)

N/A

Recruiting

Led By Jeffrey I Silberzweig, MD

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

Refractory nephrotic syndrome unresponsive to standard corticosteroid and/or calcineurin inhibitor therapy for at least 8 weeks resulting in failure to achieve complete or partial remission

Refractory nephrotic syndrome not well tolerated due to severe side effects that negatively affect quality of life without providing an acceptable level of clinical benefit

Must not have

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

Body weight < 15 kg (33.1 lbs)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1, 3, 6, 12, and 24 months after the final treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is a study to confirm the safety and efficacy of the Liposorber® LA-15 System, a blood purification therapy that selectively removes malignant lipoproteins, in the treatment of drug-resistant pediatric primary FSGS.

Who is the study for?

This trial is for children with a kidney condition called Focal Segmental Glomerulosclerosis (FSGS) who haven't responded to standard treatments. They should have a certain level of kidney function and not be on specific blood thinners or blood pressure medications that can't be paused. The study excludes those over 21, under 33.1 lbs, pregnant, or with severe heart issues among other criteria.

What is being tested?

The Liposorber® LA-15 System is being tested in this study. It's a device that filters out harmful lipoproteins from the blood which might help improve conditions related to FSGS in kids who don’t respond well to usual drugs.

What are the potential side effects?

Possible side effects may include reactions due to the removal of lipoproteins from the blood, such as changes in blood pressure or imbalances in electrolytes. There could also be risks associated with anticoagulants used during treatment.

Eligibility Criteria

Inclusion Criteria

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

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My kidney condition hasn't improved after 8 weeks of standard treatment.

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My kidney condition treatment causes severe side effects without much benefit.

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I am a child with FSGS and my kidney function is good.

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I am a child with nephrotic syndrome due to FSGS after a kidney transplant.

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My kidney condition hasn't improved with standard treatments.

Exclusion Criteria

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

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I cannot undergo Liposorber® LA-15 treatment due to severe heart or blood pressure issues.

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I weigh less than 33.1 lbs.

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I am over 21 years old.

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

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

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I am willing and able to sign the informed consent, or if under 21, my parent can.

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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 have thyroid or liver problems.

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

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I am taking ACE inhibitors that cannot be stopped for 24 hours before each apheresis treatment.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1,3, 6, 12, and 24 months after the final apheresis

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1,3, 6, 12, and 24 months after the final apheresis

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1,3, 6, 12, and 24 months after the final apheresis for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Incidence of adverse events

Nephrotic Condition

Various laboratory values

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 / 16Eligibility criteria met