Interventional Study
a clinical trial in which a new drug or device is used to measure a specific outcome.
The Liposorber Trial for Pediatric Patients with FSGS
Post Approval Study of Liposorber LA-15 System for the Treatment of Focal Segmental Glomerulosclerosis in Pediatric Patients
Brief Description
Liposorber LA-15 System is a blood processing system used outside of the body. This device removes certain lipoproteins (LDL/BDL) from the patient's blood. The Liposorber LA-15 System is used in patients diagnosed with focal segmental glomerulosclerosis (FSGS.) either before transplant, or after a kidney transplant in which there is a recurrence of FSGS.
The study is ongoing at pediatric sites.
Trial Physician / Study Coordinator
Dr. Cheryl Sanchez-Kazi, MD
EmailSite Name
Loma Linda University Health
11234 Anderson St. Room B-726
Sponsor
Kaneka Pharma America LLC
Estimated enrollment
35
Estimated end date
October, 2024
Interventional Study
a clinical trial in which a new drug or device is used to measure a specific outcome.
The Liposorber Trial for Pediatric Patients with FSGS
Post Approval Study of Liposorber LA-15 System for the Treatment of Focal Segmental Glomerulosclerosis in Pediatric Patients
Brief Description
Liposorber LA-15 System is a blood processing system used outside of the body. This device removes certain lipoproteins (LDL/BDL) from the patient's blood. The Liposorber LA-15 System is used in patients diagnosed with focal segmental glomerulosclerosis (FSGS.) either before transplant, or after a kidney transplant in which there is a recurrence of FSGS.
The study is ongoing at pediatric sites.
Trial is for people with
Primary focal segmental glomerulosclerosis (FSGS)
Post-transplant recurrent FSGS
Study Goal
This study will determine if patients with FSGS can reach partial or full remission as a result of treatment with the LA-15 system.
What is involved for the Patient?
Treatment with this system is conducted at a medical clinic, and each treatment takes approximately 2-3 hours. The system is indicated for up to 12 uses in 9 weeks of treatment (twice weekly for three weeks, then once weekly for six weeks).
About the drug or intervention
The Liposorber LA-15 System is indicated for use in the treatment of pediatric and adult patients Nephrotic Syndrome associated with primary FSGS when standard treatment options are unsuccessful or post-transplant with FSGS recurrence.