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Post Approval Study of Liposorber LA-15 System for the Treatment of Focal Segmental Glomerulosclerosis in Children (FSGS pediatric)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02235857
Recruitment Status : Recruiting
First Posted : September 10, 2014
Last Update Posted : March 8, 2023
Sponsor:
Information provided by (Responsible Party):
Kaneka Medical America LLC

Study Description
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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.


Condition or disease Intervention/treatment Phase
Focal Segmental Glomerulosclerosis Device: LIPOSORBER® LA-15 System Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Patients with focal segmental glomerulosclerosis treated by LIPOSORBER® LA-15 system
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Drug-resistant Pediatric Primary Focal Segmental Glomerulosclerosis Using the Liposorber® LA-15 System
Actual Study Start Date : May 3, 2015
Estimated Primary Completion Date : May 3, 2026
Estimated Study Completion Date : July 3, 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Device: 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.
Other Names:
  • LDL apheresis
  • LDL adsorption
  • dextran sulfate column


Outcome Measures
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Primary Outcome Measures :
  1. The percent of patients who show complete or partial remission [ Time Frame: 1 month after the final treatment ]
  2. 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 ]

Secondary Outcome Measures :
  1. Nephrotic Condition [ Time Frame: 1, 3, 6, 12, and 24 months after the final treatment ]

    Nephrotic condition defined as follows:

    urine protein:creatinine ratio > 2.0 (g/g) with a first morning void urine sample


  2. The percent of patients who obtain complete or partial remission [ Time Frame: 3, 6, 12, and 24 months after the final treatment ]
  3. Incidence of adverse events [ Time Frame: From the initiation of the first apheresis session until the termination of the last (usually 12th) apheresis session, standad period of 9 weeks for a total of 12 aoheresis sessions ]

    The protocol indicates the standard treatment schedule as follows:

    2 sessions weekly for the first 3 weeks followed by 1 session weekly for 6 weeks


  4. Incidence of adverse events and severe adverse events [ Time Frame: From 1 months to 24 months after the final aphresis ]
  5. Various laboratory values [ Time Frame: 1,3, 6, 12, and 24 months after the final apheresis ]
    Various laboratory values include Urine protein, Urine creatinine, Serum creatinine, Estimated glomerular filtration rate (eGFR), serum total protein, Serum albumin, Serum vitamin E, Hematocrit, Red blood cell, White blood cell, Platelet, Total cholesterol, LDL cholesterol, HDL cholesterol, Triglycerides, Serum soluble urokinase plasminogen activator receptor.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02235857


Contacts
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Contact: Laleh Abedinzadeh, MD 6469846538 laleh.abedinzadeh@kaneka.com

Locations
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United States, California
Loma Linda University Children's Hospital Recruiting
Loma Linda, California, United States, 92354
Contact: Cheryl P Sanchez-Kazi, MD    909-651-1904      
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Ananth S Karumanchi    310-423-7608    SAnanth.Karumanchi@csmc.edu   
United States, Delaware
Nemours/A.I. duPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
Contact: Joshua Zaritsky, MD PhD    302-651-5527    joshua.zaritsky@nemours.org   
United States, Florida
Nemours Children's Health Terminated
Orlando, Florida, United States, 32827
United States, Michigan
Helen DeVos Children's Hospital Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Alejandro Quiroga, MD    616-267-2400      
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55454
Contact: Michelle Rheault, MD    612-626-2922    rheau002@umn.edu   
United States, New York
Weill Cornell Medical Center / NewYork-Presbyterian Recruiting
New York, New York, United States, 10065
Contact: Eduardo M Perelstein, MD    646-962-4324    emperels@med.cornell.edu   
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Koyal Jain, MD         
Contact: Anne Froment    (919) 445-2622    anne_froment@med.unc.edu   
United States, Ohio
Akron Children's Hospital Recruiting
Akron, Ohio, United States, 44308
Contact: Rupesh Raina, MD    330-543-8950    RRaina@chmca.org   
Contact: Ann Pokelsek, BSN, RN,    330-543-0702    apokelsek@akronchildrens.org   
United States, Pennsylvania
St. Christopher's Hospital for Children Recruiting
Philadelphia, Pennsylvania, United States, 19134
Contact: Joshua J Zaritsky, MD    215-427-5190      
United States, South Carolina
Medical University of South Carolina Children's Hospital Recruiting
Charleston, South Carolina, United States, 29425
Contact: Katherine E Twombley, MD    843-792-8904    twombley@musc.edu   
United States, Virginia
Children's Hospital of Richmond at VCU Withdrawn
Richmond, Virginia, United States, 23219
Sponsors and Collaborators
Kaneka Medical America LLC
Investigators
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Principal Investigator: Jeffrey I Silberzweig, MD Weill Medical College of Cornell University
More Information
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Publications:

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Responsible Party: Kaneka Medical America LLC
ClinicalTrials.gov Identifier: NCT02235857    
Other Study ID Numbers: KMA-FSGS-H120005
First Posted: September 10, 2014    Key Record Dates
Last Update Posted: March 8, 2023
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Kaneka Medical America LLC:
pediatric, renal transplantation, recurrence, drug-resistant
Additional relevant MeSH terms:
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Glomerulosclerosis, Focal Segmental
Glomerulonephritis
Nephritis
Kidney Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
 Urogenital Diseases
Male Urogenital Diseases
Dextrans
Anticoagulants
Plasma Substitutes
Blood Substitutes