Actively Recruiting
Post Approval Study of Liposorber LA-15 System for the Treatment of Focal Segmental Glomerulosclerosis in Children
Led by Kaneka Medical America LLC · Updated on 2025-04-30
35
Participants Needed
12
Research Sites
687 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Liposorber® LA-15 System is a blood purification therapy that selectively removes malignant lipoproteins including low density lipoprotein from circulating blood flow and rapidly reduces the plasma cholesterol level. The system was originally developed for the treatment of patients with serious dyslipidemia such as familial hypercholesterolemia and then applied to improve the dyslipidemia, a common complication of nephrotic syndrome and found to bring about improvement not only with the dyslipidemic condition but the nephrotic condition (e.g, proteinuria and hypoproteinemia). Although the definitive mechanism by which the system may relieve nephrotic syndrome is unknown, it has been recognized as one of alternative therapies for refractory nephrotic syndrome including focal segmental glomerulosclerosis (FSGS) in Japan and referred in the Guidelines for the Treatment of Nephrotic Syndrome endorsed by The Japanese Society of Nephrology. This study is conducted as a post approval study imposed by Humanitarian Device Exemption (HDE) order to confirm the safety and efficacy of the Liposorber® LA-15 System in the treatment of drug-resistant pediatric primary FSGS.
CONDITIONS
Official Title
Post Approval Study of Liposorber LA-15 System for the Treatment of Focal Segmental Glomerulosclerosis in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pediatric patients with FSGS and a glomerular filtration rate (GFR) of at least 45 ml/min/1.73 m2
- Patients with refractory nephrotic syndrome unresponsive to corticosteroid or calcineurin inhibitor therapy for at least 8 weeks
- Patients intolerant to standard treatments due to severe side effects affecting quality of life
- Patients for whom standard therapy is contraindicated
- Pediatric post-renal transplant patients with nephrotic syndrome related to primary FSGS
You will not qualify if you...
- Patients older than 21 years
- Patients or parents unwilling or unable to sign informed consent (patients 18-21 may sign for themselves)
- Pregnant, lactating, or planning pregnancy before study completion
- Unable or unwilling to follow up as required
- Participating in another investigational drug or device study
- Body weight under 15 kg (33.1 lbs)
- Currently taking ACE inhibitors that cannot be stopped at least 24 hours before each treatment
- Currently taking other antihypertensive drugs that cannot be withheld on treatment days
- Medical conditions limiting life expectancy before study endpoint or causing noncompliance
- Allergies to dextran sulfate, heparin, or ethylene oxide
- Severe bleeding disorders or inability to achieve proper anticoagulation
- Unable to tolerate extracorporeal circulation due to severe cardiac or circulatory conditions
- Uncontrolled cardiac problems such as arrhythmia, unstable angina, heart failure, or valvular disease
- Functional thyroid disease or liver problems
- Unresolved systemic or local infection affecting study outcomes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Loma Linda University Children's Hospital
Loma Linda, California, United States, 92354
Actively Recruiting
2
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
3
Nemours/A.I. duPont Hospital for Children
Wilmington, Delaware, United States, 19803
Actively Recruiting
4
Nemours Children's Health
Orlando, Florida, United States, 32827
Terminated
5
Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
6
University of Minnesota
Minneapolis, Minnesota, United States, 55454
Actively Recruiting
7
Weill Cornell Medical Center / NewYork-Presbyterian
New York, New York, United States, 10065
Actively Recruiting
8
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
9
Akron Children's Hospital
Akron, Ohio, United States, 44308
Actively Recruiting
10
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134
Actively Recruiting
11
Medical University of South Carolina Children's Hospital
Charleston, South Carolina, United States, 29425
Actively Recruiting
12
Children's Hospital of Richmond at VCU
Richmond, Virginia, United States, 23219
Withdrawn
Research Team
A
Ayaka Kitamura
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here