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Currently Enrolling
Interventional

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

Linda Walker

Correo electrónico Teléfono
Nombre del sitio

Medical University of South Carolina
96 Jonathan Lucas Street CSB 822, MCS 629, Charleston, SC 29425

Patrocinador

Kaneka Pharma America LLC

Matrícula estimada

35

Fecha de finalización estimada

June, 2025

If there is not a site for a clinical trial nearby, you can ask the study team about the possibility of travel reimbursements (i.e., paying you back for your travel costs). Alternatively, you can ask about the possibility of participating from home.
Encuentre otras ubicaciones para esta prueba:
Actualmente inscribiéndose
intervencionista

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.

Encuentre otras ubicaciones para esta prueba:
Chapel Hill, NC
Preguntas frecuentes

Nephrotic Syndrome is not a disease itself, but rather a group of signs and symptoms that result from damage in the part of the kidney that filters blood (glomeruli).

Common symptoms include:

  • Foamy urine (called proteinuria) caused by protein “spilling” into the urine
  • Severe swelling in parts of the body, most noticeably around the eyes, hands, feet, and abdomen (called edema)
  • Weight gain due to a buildup of extra fluid
  • Fatigue
  • Loss of appetite
  • Low levels of protein in the blood (hypoalbuminemia)
  • Higher than normal fat and cholesterol levels in the blood (hyperlipidemia)

Nephrotic Syndrome can typically be diagnosed with a urine test.

Nephrotic Syndrome can be “primary” or “secondary” in nature.

Diseases that affect only the kidneys are called primary causes of Nephrotic Syndrome. Doctors often call these diseases “idiopathic,” which means that they arise from an unknown cause. Some of these diseases include:

  • Minimal Change Disease (MCD) – most common in children
  • Focal Segmental Glomerulosclerosis (FSGS)
  • Membranous Nephropathy (MN) – most common in adults
  • IgA Nephropathy (IgAN)

Secondary Nephrotic Syndrome is caused by an underlying, systemic condition like diabetes, lupus, HIV, and others.

The Kidney Health Gateway is a website owned and operated by NephCure Kidney International. The purpose of this website is to help patients with rare forms of primary Nephrotic Syndrome get connected to expert care and cutting-edge treatment options. By answering a few questions about you or your loved one’s condition, we can provide you with a list of clinical trials and/or expert doctors in your area.

If you have additional questions, please visit NephCure.org or email Info@NephCure.org.

 

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