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 (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 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 Nephrotic Syndrome associated with primary FSGS when standard treatment options are unsuccessful or post-transplant with FSGS recurrence.
- 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