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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
LIPOSORBER® LA-15 System is an extracorporeal blood purification system. Approximately 3 to 4 L of plasma is treated in a single treatment session and it takes 2 to 3 hours. Recommended frequency of the treatment is twice weekly for 3 weeks followed by once weekly for 6 weeks, thus it takes 9 weeks for a total of 12 treatment sessions.
Loma Linda University Children's Hospital
Loma Linda, California, United States
RECRUITINGCedars Sinai Medical Center
Los Angeles, California, United States
RECRUITINGNemours/A.I. duPont Hospital for Children
Wilmington, Delaware, United States
RECRUITINGNemours Children's Health
Orlando, Florida, United States
TERMINATEDHelen DeVos Children's Hospital
Grand Rapids, Michigan, United States
RECRUITINGUniversity of Minnesota
Minneapolis, Minnesota, United States
RECRUITINGWeill Cornell Medical Center / NewYork-Presbyterian
New York, New York, United States
RECRUITINGUniversity of North Carolina
Chapel Hill, North Carolina, United States
RECRUITINGAkron Children's Hospital
Akron, Ohio, United States
RECRUITINGSt. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States
RECRUITING...and 2 more locations
The percent of patients who show complete or partial remission
Time frame: 1 month after the final treatment
the rate of device-related and procedure-related serious adverse events
Time frame: During the period in which the apheresis procedures are administered and up to at the 1-month follow-up visit
Nephrotic Condition
Nephrotic condition defined as follows: urine protein:creatinine ratio \> 2.0 (g/g) with a first morning void urine sample
Time frame: 1, 3, 6, 12, and 24 months after the final treatment
The percent of patients who obtain complete or partial remission
Time frame: 3, 6, 12, and 24 months after the final treatment
Incidence of adverse events
The protocol indicates the standard treatment schedule as follows: 2 sessions weekly for the first 3 weeks followed by 1 session weekly for 6 weeks
Time frame: From the initiation of the first apheresis session until the termination of the last (usually 12th) apheresis session, standad period of 9 weeks for a total of 12 aoheresis sessions
Incidence of adverse events and severe adverse events
Time frame: From 1 months to 24 months after the final aphresis
Various laboratory values
Various laboratory values include Urine protein, Urine creatinine, Serum creatinine, Estimated glomerular filtration rate (eGFR), serum total protein, Serum albumin, Serum vitamin E, Hematocrit, Red blood cell, White blood cell, Platelet, Total cholesterol, LDL cholesterol, HDL cholesterol, Triglycerides, Serum soluble urokinase plasminogen activator receptor.
Time frame: 1,3, 6, 12, and 24 months after the final apheresis
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