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Extracorporeal Blood Treatment

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

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month after the final apheresis treatment.
Awards & highlights

FSGSALLAGE Trial Summary

This trial will study whether the LIPOSORBER® LA-15 System is an effective and safe treatment for patients with nephrotic syndrome associated with FSGS who have failed or not well tolerated standard treatments.

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.Check my eligibility
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.See study design
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.

FSGSALLAGE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have FSGS with unsuccessful standard treatments and my kidney function is still okay.
Select...
I have had a kidney transplant.

FSGSALLAGE Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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.

FSGSALLAGE 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.

Find a Location

Who is running the clinical trial?

Kaneka Medical America LLCLead Sponsor
11 Previous Clinical Trials
669 Total Patients Enrolled

Media Library

LIPOSORBER® LA-15 (Extracorporeal Blood Treatment) Clinical Trial Eligibility Overview. Trial Name: NCT04065438 — N/A
Focal Segmental Glomerulosclerosis Research Study Groups: LIPOSORBER® LA-15 System
Focal Segmental Glomerulosclerosis Clinical Trial 2023: LIPOSORBER® LA-15 Highlights & Side Effects. Trial Name: NCT04065438 — N/A
LIPOSORBER® LA-15 (Extracorporeal Blood Treatment) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04065438 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many physical sites are conducting this investigation?

"This investigation is actively being conducted in 10 different sites, including Chapel Hill, Akron and Wilmington. To limit any necessary journeying for enrolment, participants should carefully select the trials nearest to them."

Answered by AI

How many people have enrolled in this research project?

"Absolutely. Clinicaltrials.gov indicates that this research trial, which was first uploaded on January 1st 2020, is actively looking to enrol participants. 35 people are needed from 10 different sites."

Answered by AI

Does this research have any age restrictions?

"In accordance with the eligibility criteria, children under 0 and adults up to 75 years old may participate in this clinical research."

Answered by AI

Are there any openings in this clinical research study?

"That is accurate. According to the data on clinicaltrials.gov, this experiment was first advertised in January 2020 and has been actively seeking participants since then with a most recent update occurring at the end of March 2021. The trial requires 35 volunteers from 10 medical sites."

Answered by AI

What prerequisites must be met in order to become a participant of this medical experiment?

"The trial seeks 35 hyalinosis, segmental glomerular patients aged between 0-75. To be eligible for the study, individuals must have either failed to respond or experienced adverse effects from corticosteroid and/or calcineurin inhibitors treatments with a GFR ≥45 ml/min/1.73 m2., or they should already had undergone renal transplantation."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Post Approval Study for Treatment of Drug-resistant Adult and Pediatric Primary FSGS Using the LIPOSORBER® LA-15 System
2020. "Post Approval Study for Treatment of Drug-resistant Adult and Pediatric Primary FSGS Using the LIPOSORBER® LA-15 System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04065438.
~11 spots leftby Apr 2026
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