Post Approval Study for Treatment of Drug-resistant Adult and Pediatric Primary FSGS Using the LIPOSORBER® LA-15 System (NCT04065438)
Treatment of Drug-resistant Adult and Pediatrc Primary Focal Segmental Glomerulosclerosis and Post -Transplant Recurrence Using the LIPOSORBER® LA-15 System
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (16 items).
Location: Loma Linda University Children's Hospital — Loma Linda, California
Age range: Not specified to 75 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria: General Exclusion Criteria
- Patient is greater than 75 years of age at the start of the treatment period or less than 22
- The patient is unwilling or unable to sign and date the informed consent
- Pregnant, lactating, or planning to become pregnant prior to completing the study (Note: The safety of the use of LIPOSORBER® in pregnant women has not been studied. There may be unknown risks to an embryo/fetus. Sexually active women of childbearing potential should avoid pregnancy during the use of the LIPOSORBER device and throughout the study duration.)
- Unable or unwilling to comply with the follow-up schedule
- Simultaneously participating in another investigational drug or device study
- Body weight \< 15 kg (33.1 lbs) Medical Exclusion Criteria
- Currently being administered ACE inhibitors that cannot be withheld for at least 24 hours prior to each apheresis treatment (Note: The time period to withhold ACE inhibitors should be prolonged, if determined by the treating physician, considering each individual's renal function and the biological half-life of the ACE-inhibitor currently in use.)
- Currently being administered antihypertensive drugs other than ACE inhibitors (e.g., ARBs) that cannot be withheld on the day of apheresis until after the procedure
- Medical condition or disorder that would limit life expectancy to less than the primary clinical study endpoint or that may cause noncompliance with the study plan or confound the data analysis
- Hypersensitivity to dextran sulfate, heparin, or ethylene oxide
- Adequate anticoagulation cannot be achieved due to severe hemophilia, severe hemorrhage diathesis, severe gastrointestinal ulcers, or are recipients of vitamin K antagonist medications
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (10 Sites)
- Loma Linda University Children's Hospital — Loma Linda, California
- Loma Linda University Hospital — Loma Linda, California
- Nemours/Alfred I DuPont Hospital for Children — Wilmington, Delaware
- Helen DeVos Children's Hospital — Grand Rapids, Michigan
- Weill Cornell Medicine / NewYork-Presbyterian — New York, New York
- University of North Carolina — Chapel Hill, North Carolina
- Akron Children's Hospital — Akron, Ohio
- Medical University of South Carolina Children's Hospital — Charleston, South Carolina
- Medical University of South Carolina — Charleston, South Carolina
- Children's Hospital of Richmond at VCU — Richmond, Virginia
📞 Contact the Study Coordinator
Phone: +81-74431813933
Email: Ayaka.Kitamura1@kaneka.co.jp
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Focal Segmental Glomerulosclerosis
- An Open-Label Phase 2 Study of N-Acetyl-D-Mannosamine (ManNAc) in Subjects With Podocyte Diseases — Bethesda, Maryland
- Post Approval Study of Liposorber LA-15 System for the Treatment of Focal Segmental Glomerulosclerosis in Children — Loma Linda, California
- Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases — Los Angeles, California
- A Study of Praliciguat in Participants With Focal Segmental Glomerulosclerosis (FSGS) — Chula Vista, California
- Recurrence Post-transplant Observational Study in Focal Segmental Glomerulosclerosis and Minimal Change Disease — Ann Arbor, Michigan
Explore by condition: All Focal Segmental Glomerulosclerosis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.