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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms

  • Focal Segmental Glomerulosclerosis
  • Glomerulosclerosis, Focal Segmental

NCT number NCT02235857
Study type Interventional
Source Kaneka Medical America LLC
Contact Laleh Abedinzadeh, MD
Phone 6469846538
Email laleh.abedinzadeh@kaneka.com
Status Recruiting
Phase N/A
Start date May 3, 2015
Completion date July 3, 2028

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