The Liposorber Trial for FSGS
Post Approval Study of Liposorber LA-15 System for the Treatment of Focal Segmental Glomerulosclerosis in Children
Liposorber LA-15 System is a blood processing system used outside of the body. This device removes certain lipoproteins 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.
Wilmington, DE is a pediatric-only site.
Trial for people with
Primary focal segmental glomerulosclerosis (FSGS)
Post-transplant recurrent FSGS
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 with nephrotic syndrome associated with primary FSGS when standard treatment options are unsuccessful or the patient is post renal transplantation.
- Study CoordinatorRupesh Raina, MD; Samantha Formica, BSN, RN, CPN
- Study Coordinator Emailrraina@chmca.org ; firstname.lastname@example.org
- Study Coordinator Phone330-543-8950
- Site NameAkron Children's Hospital
- Address130 W. Exchange Street
- SponsorKaneka Pharma America LLC
- Study Drugn/a
- Estimated enrollment35
- Estimated end dateOctober, 2024