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
Breve descripción
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.
Médico del ensayo / Coordinador del estudio
Anne Froment
Correo electrónicoNombre del sitio
University of North Carolina at Chapel Hill
University of North Carolina at Chapel Hill, Division of Nephrology and Hypertension 7024 Burnett-Womack CB7155 Chapel Hill, NC 27599-7155
Patrocinador
Kaneka Pharma America LLC
Matrícula estimada
35
Fecha de finalización estimada
June, 2025
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
Breve descripción
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.
La prueba es para personas con
Primary focal segmental glomerulosclerosis (FSGS)
Post-transplant recurrent FSGS
Objetivo del estudio
This study will determine if patients with drug-resistant FSGS will benefit from the LA-15 system.
¿Qué implica para el paciente?
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).
Sobre el medicamento o la intervención
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.