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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 1 months to 24 months after the final aphresis
Awards & highlights
FSGS pediatric Trial 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.Check my eligibility
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.See study design
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.
FSGS pediatric Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Select...
I am a child with FSGS and my kidney function is good.
Select...
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.
FSGS pediatric Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from 1 months to 24 months after the final aphresis
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 1 months to 24 months after the final aphresis
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The percent of patients who show complete or partial remission
the rate of device-related and procedure-related serious adverse events
Secondary outcome measures
Incidence of adverse events
Incidence of adverse events and severe adverse events
Nephrotic Condition
+2 moreFSGS pediatric 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.
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Who is running the clinical trial?
Kaneka Medical America LLCLead Sponsor
11 Previous Clinical Trials
669 Total Patients Enrolled
Jeffrey I Silberzweig, MDPrincipal InvestigatorWeill Medical College of Cornell University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot undergo Liposorber® LA-15 treatment due to severe heart or blood pressure issues.I weigh less than 33.1 lbs.I am over 21 years old.I do not have serious heart problems like uncontrolled irregular heartbeat or severe heart failure.My kidney condition hasn't improved after 8 weeks of standard treatment.I cannot or do not want to follow the study's visit schedule.My kidney condition treatment causes severe side effects without much benefit.I am willing and able to sign the informed consent, or if under 21, my parent can.I am taking blood pressure medicine that isn't an ACE inhibitor and can't stop it for apheresis.I am a child with FSGS and my kidney function is good.I am a child with nephrotic syndrome due to FSGS after a kidney transplant.I have thyroid or liver problems.My kidney condition hasn't improved with standard treatments.I cannot take blood thinners due to severe bleeding disorders or stomach ulcers.You are allergic to dextran sulfate, heparin, or ethylene oxide.I am taking ACE inhibitors that cannot be stopped for 24 hours before each apheresis treatment.I do not have any ongoing infections that could interfere with the study.
Research Study Groups:
This trial has the following groups:- Group 1: Liposorber® LA-15 System
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have been recruited to take part in this clinical trial?
"The study requires 35 suitable candidates, who meet the selection criteria. Kaneka Medical America LLC is overseeing this trial and it will be conducted at multiple locales including Weill Cornell Medical Center/NewYork-Presbyterian in New york City and University of North carolina in Chapel Hill."
Answered by AI
How many venues are presently conducting this research trial?
"Numerous medical centres are furnishing patients for this trial - Weill Cornell Medical Center / NewYork-Presbyterian in New york, University of North carolina in Chapel Hill and Loma Linda University Children's Hospital in Loma Linda being a few. Altogether, 10 sites are recruiting participants."
Answered by AI
Is the enrollment process for this clinical trial still in progress?
"Clinicaltrials.gov has indicated that recruitment for this trial is still underway. It was initially published on March 1st 2015, and the last update occured on March 28th 2022."
Answered by AI
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