Last updated on September 2018

Post Approval Study of Liposorber LA-15 System for the Treatment of Focal Segmental Glomerulosclerosis in Children

Brief description of study

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.

Clinical Study Identifier: NCT02235857

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Joshua Zaritsky, MD PhD

Nemours/A.I. duPont Hospital for Children
Wilmington, DE United States
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Laleh Abedinzadeh, MD

Nemours Children's Hospital, Orlando
Orlando, FL United States
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Rupesh Raina, MD

Akron Children's Hospital
Akron, OH United States
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Cheryl P Sanchez-Kazi, MD

Loma Linda University Children's Hospital
Loma Linda, CA United States
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Alejandro Quiroga, MD

Helen DeVos Children's Hospital
Grand Rapids, MI United States
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Katherine E Twombley, MD

Medical University of South Carolina Children's Hospital
Charleston, SC United States
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Megan M Lo, MD

Children's Hospital of Richmond at VCU
Richmond, VA United States
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