Condition: Focal Segmental Glomerulosclerosis · Sponsor: Kaneka Medical America LLC
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.
This description comes directly from the study's public registry record.
Ayaka Kitamura · +81-74431813933 · Ayaka.Kitamura1@kaneka.co.jp
Always discuss trial participation with your own doctor first.
| Loma Linda University Children's Hospital | Loma Linda, California, United States | Recruiting |
| Cedars Sinai Medical Center | Los Angeles, California, United States | Recruiting |
| Nemours/A.I. duPont Hospital for Children | Wilmington, Delaware, United States | Recruiting |
| Nemours Children's Health | Orlando, Florida, United States | Terminated |
| Helen DeVos Children's Hospital | Grand Rapids, Michigan, United States | Recruiting |
| University of Minnesota | Minneapolis, Minnesota, United States | Recruiting |
| Weill Cornell Medical Center / NewYork-Presbyterian | New York, New York, United States | Recruiting |
| University of North Carolina | Chapel Hill, North Carolina, United States | Recruiting |
| Akron Children's Hospital | Akron, Ohio, United States | Recruiting |
| St. Christopher's Hospital for Children | Philadelphia, Pennsylvania, United States | Recruiting |
| Medical University of South Carolina Children's Hospital | Charleston, South Carolina, United States | Recruiting |
| Children's Hospital of Richmond at VCU | Richmond, Virginia, United States | Withdrawn |
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Source record: clinicaltrials.gov/study/NCT02235857