Recruiting

Liposorber LA-15

Sponsor:

Kaneka Medical America LLC

Code:

NCT02235857

Conditions

Focal Segmental Glomerulosclerosis

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Interventions

LIPOSORBER® LA-15 System

Study Details

Brief summary:

Liposorber® LA-15 System is a blood purification therapy that selectively removes malignant lipoproteins including low density lipoprotein from circulating blood flow and rapidly reduces the plasma cholesterol level. The system was originally developed for the treatment of patients with serious dyslipidemia such as familial hypercholesterolemia and then applied to improve the dyslipidemia, a common complication of nephrotic syndrome and found to bring about improvement not only with the dyslipidemic condition but the nephrotic condition (e.g, proteinuria and hypoproteinemia).

Although the definitive mechanism by which the system may relieve nephrotic syndrome is unknown, it has been recognized as one of alternative therapies for refractory nephrotic syndrome including focal segmental glomerulosclerosis (FSGS) in Japan and referred in the Guidelines for the Treatment of Nephrotic Syndrome endorsed by The Japanese Society of Nephrology.

This study is conducted as a post approval study imposed by Humanitarian Device Exemption (HDE) order to confirm the safety and efficacy of the Liposorber® LA-15 System in the treatment of drug-resistant pediatric primary FSGS.

Conditions

Focal Segmental Glomerulosclerosis

Study ID

NCT02235857

Start date

May 3, 2015

Status verified date

Aug, 2026

Completion date

Sep 30, 2029

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

35 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Liposorber® LA-15 System

All study patients who meet the study eligibility criteria will undergo the extracorporeal treatment using Liposorber® LA-15 System. The participants are to be treated with the system twice weekly for the 3weeks and then once weekly for the following 6 weeks.

Interventions

LIPOSORBER® LA-15 System

LIPOSORBER® LA-15 System is an extracorporeal blood purification system. Approximately 3 to 4 L of plasma is treated in a single treatment session and it takes 2 to 3 hours. Recommended frequency of the treatment is twice weekly for 3 weeks followed by once weekly for 6 weeks, thus it takes 9 weeks for a total of 12 treatment sessions.

Primary outcome measure

  • The percent of patients who show complete or partial remission [ Time Frame: 1 month after the final treatment ]
  • the rate of device-related and procedure-related serious adverse events [ Time Frame: During the period in which the apheresis procedures are administered and up to at the 1-month follow-up visit ]

Central Contacts and Locations

Central contacts

Ayaka Kitamura

+81-74431813933Ayaka.Kitamura1@kaneka.co.jp

Locations

Loma Linda University Children's Hospital

Recruiting

Loma Linda, California, United States, 92354

Contacts

Cheryl P Sanchez-Kazi, MD

909-651-1904

Cedars Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Ananth S Karumanchi

310-423-7608SAnanth.Karumanchi@csmc.edu

Nemours/A.I. duPont Hospital for Children

Recruiting

Wilmington, Delaware, United States, 19803

Contacts

Joshua Zaritsky, MD PhD

302-651-5527joshua.zaritsky@nemours.org

Helen DeVos Children's Hospital

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Alejandro Quiroga, MD

616-267-2400

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55454

Contacts

Michelle Rheault, MD

612-626-2922rheau002@umn.edu

Weill Cornell Medical Center / NewYork-Presbyterian

Recruiting

New York, New York, United States, 10065

Contacts

Eduardo M Perelstein, MD

646-962-4324emperels@med.cornell.edu

University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Anne Froment

(919) 445-2622anne_froment@med.unc.edu

Akron Children's Hospital

Recruiting

Akron, Ohio, United States, 44308

Contacts

Rupesh Raina, MD

330-543-8950RRaina@chmca.org

Ann Pokelsek, BSN, RN,

330-543-0702apokelsek@akronchildrens.org

St. Christopher's Hospital for Children

Recruiting

Philadelphia, Pennsylvania, United States, 19134

Contacts

Joshua J Zaritsky, MD

215-427-5190

Medical University of South Carolina Children's Hospital

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Katherine E Twombley, MD

843-792-8904twombley@musc.edu

More Information

Sponsor

Kaneka Medical America LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Keywords

  • pediatric, renal transplantation, recurrence, drug-resistant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Kaneka Medical America LLC on 2026-08-28.