Actively Recruiting
Post Approval Study for Treatment of Drug-resistant Adult and Pediatric Primary FSGS Using the LIPOSORBER® LA-15 System
Led by Kaneka Medical America LLC · Updated on 2024-10-09
35
Participants Needed
10
Research Sites
439 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This multicenter, prospective, single-arm clinical study will evaluate the probable benefit and safety of the LIPOSORBER® LA-15 System for the treatment of adult patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis, when the standard treatment options, including corticosteroid and/or calcineurin inhibitors treatments, have been unsuccessful or not well tolerated, and the patient has a GFR ≥ 45 ml/min/1.73m2, or the patient has post-renal transplant recurrence. Treatment for FSGS is considered unsuccessful if the patient is unresponsive to standard therapy (e.g., at least 8 weeks of corticosteroids) and fails to achieve complete or partial remission. A standard treatment is considered not well tolerated if the patient experiences severe side effects without providing an acceptable level of clinical benefit.
CONDITIONS
Official Title
Post Approval Study for Treatment of Drug-resistant Adult and Pediatric Primary FSGS Using the LIPOSORBER® LA-15 System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has nephrotic syndrome associated with primary FSGS
- Standard treatments including corticosteroids and/or calcineurin inhibitors have been unsuccessful or not well tolerated
- Patient has a glomerular filtration rate (GFR) 45 ml/min/1.73 m2
- Patient is post renal transplantation
You will not qualify if you...
- Age less than 22 years or greater than 75 years at treatment start
- Unable or unwilling to provide informed consent
- Pregnant, breastfeeding, or planning pregnancy during the study
- Unable or unwilling to comply with follow-up schedule
- Participating in another investigational drug or device study
- Body weight less than 15 kg (33.1 lbs)
- Currently taking ACE inhibitors that cannot be withheld 24 hours before treatment
- Taking other antihypertensive drugs that cannot be withheld on treatment day
- Medical conditions limiting life expectancy or study compliance
- Allergic to dextran sulfate, heparin, or ethylene oxide
- Cannot achieve adequate anticoagulation due to bleeding disorders or certain medications
- Cannot tolerate extracorporeal circulation due to severe cardiac or blood pressure conditions
- Cardiac impairments like uncontrolled arrhythmia, unstable angina, heart failure, or valve disease
- Functional thyroid disease or liver abnormalities
- Unresolved infections that could affect study outcomes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Loma Linda University Children's Hospital
Loma Linda, California, United States, 92354
Actively Recruiting
2
Loma Linda University Hospital
Loma Linda, California, United States, 92354
Actively Recruiting
3
Nemours/Alfred I DuPont Hospital for Children
Wilmington, Delaware, United States, 19803
Actively Recruiting
4
Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
5
Weill Cornell Medicine / NewYork-Presbyterian
New York, New York, United States, 10065
Actively Recruiting
6
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
7
Akron Children's Hospital
Akron, Ohio, United States, 44308
Actively Recruiting
8
Medical University of South Carolina Children's Hospital
Charleston, South Carolina, United States, 29425
Actively Recruiting
9
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
10
Children's Hospital of Richmond at VCU
Richmond, Virginia, United States, 23298
Actively Recruiting
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
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