Interventional Study
a clinical trial in which a new drug or device is used to measure a specific outcome.
The Liposorber Trial for Adults with FSGS
Post Approval Study of Liposorber LA-15 System for the Treatment of Drug-Resistant Focal Segmental Glomerulosclerosis in Adults
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.
Trial Physician / Study Coordinator
Linda Walker
Email Phone 843-792-6109Site Name
Medical University of South Carolina
96 Jonathan Lucas Street CSB 822, MCS 629, Charleston, SC 29425
Interventional Study
a clinical trial in which a new drug or device is used to measure a specific outcome.
The Liposorber Trial for Adults with FSGS
Post Approval Study of Liposorber LA-15 System for the Treatment of Drug-Resistant Focal Segmental Glomerulosclerosis in Adults
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.
Eligibility Criteria
Patient Population
Primary focal segmental glomerulosclerosis (FSGS)
Post-transplant recurrent FSGS
Age
22 — 26+
History of transplant allowed?
Yes, No
History of dialysis allowed?
No
eGFR
45 — > 60
UPCR
1.0 or Less — 3.0 or Above
Permitted medication history
Ace Inhibitors/ARB, Prednisone (Steroids), Abatacept, Acthar, Cellcept (AKA Mycophenolate), Prograf (AKA Tacrolimus), Rituximab (AKA Rituxan), Other
Patient should be
Treatment Resistant, Neither of These, Steroid Dependent
About the Drug
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).
Sponsor
Kaneka Pharma America LLC
Estimated End Date
June, 2025
About the Trial
Study Goal
This study will determine if patients with drug-resistant FSGS will benefit from the LA-15 system.
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.