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: Review the eligibility criteria below.
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 ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 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
- Genetic Causes of FSGS, Nephrotic Syndrome, or Kidney Failure — Boston, Massachusetts
- 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
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.