Post Approval Study of Liposorber LA-15 System for the Treatment of Focal Segmental Glomerulosclerosis in Children (NCT02235857)
Treatment of Drug-resistant Pediatric Primary Focal Segmental Glomerulosclerosis Using the Liposorber® LA-15 System
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Loma Linda University Children's Hospital — Loma Linda, California
Age range: Not specified to 21 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 (12 Sites)
- Loma Linda University Children's Hospital — Loma Linda, California
- Cedars Sinai Medical Center — Los Angeles, California
- Nemours/A.I. duPont Hospital for Children — Wilmington, Delaware
- Nemours Children's Health — Orlando, Florida
- Helen DeVos Children's Hospital — Grand Rapids, Michigan
- University of Minnesota — Minneapolis, Minnesota
- Weill Cornell Medical Center / NewYork-Presbyterian — New York, New York
- University of North Carolina — Chapel Hill, North Carolina
- Akron Children's Hospital — Akron, Ohio
- St. Christopher's Hospital for Children — Philadelphia, Pennsylvania
- Medical University of South Carolina Children's Hospital — 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 for Treatment of Drug-resistant Adult and Pediatric Primary FSGS Using the LIPOSORBER® LA-15 System — 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.