Post Approval Study of Liposorber LA-15 System for the Treatment of Focal Segmental Glomerulosclerosis in Children
Start Date
5/3/2015
Completion Date
7/3/2028
Summary
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.
Eligibility Criteria
Age Range: No minimum to 21 years
Interventions
LIPOSORBER® LA-15 System
Conditions
Locations
Loma Linda University Children's Hospital
Loma Linda, California 92354
United States
Cedars Sinai Medical Center
Los Angeles, California 90048
United States
Nemours/A.I. duPont Hospital for Children
Wilmington, Delaware 19803
United States
Nemours Children's Health
Orlando, Florida 32827
United States
Helen DeVos Children's Hospital
Grand Rapids, Michigan 49503
United States
University of Minnesota
Minneapolis, Minnesota 55454
United States
Weill Cornell Medical Center / NewYork-Presbyterian
New York, New York 10065
United States
University of North Carolina
Chapel Hill, North Carolina 27599
United States
Akron Children's Hospital
Akron, Ohio 44308
United States
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania 19134
United States
Medical University of South Carolina Children's Hospital
Charleston, South Carolina 29425
United States
Children's Hospital of Richmond at VCU
Richmond, Virginia 23219
United States