Currently Enrolling
Interventional

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

Alejandro Quiroga, MD

Email Phone (616) 267-2400
Site Name

Helen DeVos Children's Hospital / Spectrum Health
100 Michigan NE, Mail Code 038

Find other locations for this trial:
Currently Enrolling
Interventional

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.

Find other locations for this trial:
Grand Rapids, MI
Frequently Asked Questions

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.

 

See other frequently asked questions