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
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
Samantha Formica, BSN, RN, CPN
Email Phone 330-543-8950Site Name
Akron Children's Hospital
130 W. Exchange Street
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
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.
Eligibility Criteria
Patient Population
Primary focal segmental glomerulosclerosis (FSGS)
Post-transplant recurrent FSGS
Age
5 — 21
History of transplant allowed?
No, Yes
History of dialysis allowed?
No, Yes
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
Target Enrollment
35
Estimated End Date
October, 2024
About the Trial
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.
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.