Blood purification therapy for children with Focal Segmental Glomerulosclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the Liposorber® LA-15 System, a blood purification therapy designed to selectively remove harmful lipoproteins from the blood, in pediatric patients suffering from Focal Segmental Glomerulosclerosis (FSGS). The therapy aims to improve nephrotic syndrome symptoms, such as proteinuria and hypoproteinemia, particularly in cases where standard treatments have failed or are not tolerated. The study is conducted as a post-approval assessment to gather further data on the efficacy and safety of this treatment in children. It targets patients with refractory nephrotic syndrome or those who have undergone renal transplantation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* A pediatric patient is deemed suitable for inclusion in the study if the patient has FSGS with a GFR ≥ 45 ml/min/1.73 m 2 and any of the following:

  * Refractory nephrotic syndrome in which standard treatment options are unsuccessful (i.e., patient is unresponsive to standard corticosteroid and/or calcineurin inhibitor therapy for at least 8 weeks resulting in failure to achieve complete or partial remission);
  * Refractory nephrotic syndrome in which standard treatment options are not well tolerated (i.e., patients intolerant to standard therapies due to severe side effects that negatively affect quality of life without providing an acceptable level of clinical benefit);
  * Refractory or recurrent nephrotic syndrome in which standard therapy is contraindicated.

or

\- Pediatric post renal transplant patients with nephrotic syndrome associated with primary FSGS.

Exclusion Criteria:

* General Exclusion Criteria

  * Patient is greater than 21 years of age
  * Parent or patient is unwilling or unable to sign and date the informed consent (Note: Only patients 18-21 years of age may sign the informed consent on their own behalf)
  * Pregnant, lactating, or planning to become pregnant prior to completing the study (Note: The safety of the use of Liposorber® in pregnant women has not been studied. There may be unknown risks to an embryo/fetus. Sexually active women of child bearing potential should avoid pregnancy during the use of the Liposorber device and throughout the study duration.)
  * Unable or unwilling to comply with the follow-up schedule
  * Simultaneously participating in another investigational drug or device study
  * Body weight \< 15 kg (33.1 lbs)
* Medical Exclusion Criteria

  * Currently being administered ACE inhibitors that cannot be withheld for at least 24 hours prior to each apheresis treatment (Note: The time period to withhold ACE inhibitors should be prolonged, if determined by the treating physician, considering each individual's renal function and the biological half-life of the ACE-inhibitor currently in use.)
  * Currently being administered antihypertensive drugs other than ACE inhibitors (e.g., Angiotensin II receptor blockers (ARBs) that cannot be withheld on the day of apheresis until after the procedure
  * Medical condition or disorder that would limit life expectancy to less than the primary clinical study endpoint or that may cause noncompliance with the study plan or confound the data analysis
  * Hypersensitivity to dextran sulfate, heparin, or ethylene oxide
  * Adequate anticoagulation cannot be achieved due to severe hemophilia, severe hemorrhage diathesis, severe gastrointestinal ulcers, or are recipients of vitamin K antagonist medications
  * Extracorporeal circulation therapy with Liposorber® LA-15 System cannot be tolerated due to severe cardiac insufficiency, acute myocardial infarction, severe cardiac arrhythmia, acute apoplexy, severe uncontrollable hypertension, or severe uncontrollable hypotension
  * Cardiac impairments such as uncontrolled arrhyth¬mia, unstable angina, decompensated congestive heart failure, or valvular disease
  * Functional thyroid disease or liver abnormalities
  * Unresolved systemic or local infection that could affect the clinical study outcomes

Where it's running

• Loma Linda University Children's Hospital
  Loma Linda, California, United States Recruiting
• Cedars Sinai Medical Center
  Los Angeles, California, United States Recruiting
• Nemours/A.I. duPont Hospital for Children
  Wilmington, Delaware, United States Recruiting
• Helen DeVos Children's Hospital
  Grand Rapids, Michigan, United States Recruiting
• University of Minnesota
  Minneapolis, Minnesota, United States Recruiting
• Weill Cornell Medical Center / NewYork-Presbyterian
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Jeffrey I Silberzweig, MD — Weill Medical College of Cornell University
• Study coordinator: Ayaka Kitamura
• Email: Ayaka.Kitamura1@kaneka.co.jp
• Phone: +81-74431813933

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Praliciguat treatment for adults with focal segmental glomerulosclerosis (FSGS)

  This will test if praliciguat lowers urine protein in adults with biopsy-confirmed FSGS.

  Recruiting at 31 sites Phase 2 Akebia Therapeutics · Chula Vista, California and 31 other locations · NCT07268638

• BI 764198 for adults and adolescents with focal segmental glomerulosclerosis (FSGS).

  This study will test BI 764198 tablets taken once daily for up to two years in adults and adolescents with FSGS to see if it lowers urine protein and preserves kidney function.

  Recruiting at 253 sites Phase 3 Boehringer Ingelheim · Alabaster, Alabama and 314 other locations · NCT07220083

• Testing ManNAc for treating kidney disease FSGS

  This study is testing if a new oral treatment called ManNAc can help adults with kidney disease FSGS by reducing protein levels in their urine and checking how safe it is over 12 weeks.

  Recruiting Phase 2 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT06664814

• Evaluating treatments for kidney diseases in young to middle-aged adults

  This study is testing three different treatments for kidney diseases in young to middle-aged adults to see if they can reduce protein levels in urine and help with symptoms over 24 weeks.

  Recruiting at 78 sites Phase 2 Sanofi · Birmingham, Alabama and 78 other locations · NCT06500702

• Registry and biobank for resistant nephrotic syndrome treatment responses

  This study is collecting information from patients with resistant nephrotic syndrome to see how different treatments work and to help find better options for the future.

  Recruiting Medical University of Vienna · Vienna · NCT06162546

• Using Metformin to Improve Kidney Health in FSGS

  This study is testing if taking extended-release Metformin along with regular treatment can help improve kidney health in people with Focal Segmental Glomerulosclerosis (FSGS).

  Recruiting at 2 sites Phase 1/2 Yale University · New Haven, Connecticut and 1 other locations · NCT06090227

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.