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Post Approval Study for Treatment of Drug-resistant Adult Primary FSGS Using the LIPOSORBER® LA-15 System (PAS-Adult)

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: NCT04065438
Recruitment Status : Recruiting
First Posted : August 22, 2019
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Kaneka Pharma America LLC

Brief Summary:
This multicenter, prospective, single-arm clinical study will evaluate the probable benefit and safety of the LIPOSORBER® LA-15 System for the treatment of adult patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis, when the standard treatment options, including corticosteroid and/or calcineurin inhibitors treatments, have been unsuccessful or not well tolerated, and the patient has a GFR ≥ 60 ml/min/1.73m2, or the patient has post-renal transplant recurrence. Treatment for FSGS is considered unsuccessful if the patient is unresponsive to standard therapy (e.g., at least 8 weeks of corticosteroids) and fails to achieve complete or partial remission. A standard treatment is considered not well tolerated if the patient experiences severe side effects without providing an acceptable level of clinical benefit.

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

Detailed Description:

This study will enroll up to 35 adult patients at 3-10 clinical sites. The duration of the treatment phase of the study will take approximately 9 weeks for a total of 12 apheresis treatments with the LIPOSORBER® LA-15 System; the treatments will be given twice weekly for 3 weeks followed by once weekly for 6 weeks. Patients will undergo follow-up at 1, 3, 6, 12, and 24 months after the final apheresis treatment.

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 primary FSGS and post Transplant recurrence.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Drug-resistant Adult Primary Focal Segmental Glomerulosclerosis and Post -Transplant Recurrence Using the LIPOSORBER® LA-15 System
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : April 1, 2023
Estimated Study Completion Date : June 1, 2025


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

LIPOSORBER® LA-15 is a blood purification therapy; selectively removes apoprotein B-containing lipoproteins such as LDL from circulating blood and rapidly reduces the plasma cholesterol level. It was originally developed for prevention of coronary atherosclerosis progression in patients with serious hyperlipidemia such as familial hypercholesterolemia.

In the late 1980's, LDL-A was used to improve dyslipidemia in Nephrotic Syndrome, initially to prevent organ damage. LDL-A was found to improve both the dyslipidemic condition and clinical symptoms (proteinuria and hypoproteinemia).





Primary Outcome Measures :
  1. Evaluate the safety and probable benefit of the LIPOSORBER® LA-15 System in relieving nephrotic syndrome associated with primary FSGS at 1 month after the final apheresis treatment. partial remission at 1 month after the final apheresis treatment. [ Time Frame: 1 month after the final Apheresis treatment. ]
    The primary probable benefit endpoint will be assessed by calculating the percent reduction in Up/c values at screening and at 1 month after the final apheresis.


Secondary Outcome Measures :
  1. Nephrotic condition at 1, 3, 6, 12, and 24 months after the final apheresis treatment, including the percentage of patients who obtain complete or partial remission at 3, 6, 12, and 24 months. [ Time Frame: 1, 3, 6, 12, and 24 months after the final treatment ]


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:   22 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

A patient is deemed suitable for inclusion in the study if the patient has nephrotic syndrome associated with primary FSGS when:

• Standard treatment options, including corticosteroid and/or calcineurin inhibitors, are unsuccessful or not well tolerated and the patient's glomerular filtration rate (GFR) ≥ 60 ml/min/1.73 m2.

or

• The patient is post renal transplantation.

Exclusion Criteria:

General Exclusion Criteria

  1. Patient is greater than 75 years of age at the start of the treatment period or less than 22
  2. The patient is unwilling or unable to sign and date the informed consent
  3. 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 childbearing potential should avoid pregnancy during the use of the LIPOSORBER device and throughout the study duration.)
  4. Unable or unwilling to comply with the follow-up schedule
  5. Simultaneously participating in another investigational drug or device study
  6. Body weight < 18 kg (39.7 lbs)

Medical Exclusion Criteria

  1. 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.)
  2. Currently being administered antihypertensive drugs other than ACE inhibitors (e.g., ARBs) that cannot be withheld on the day of apheresis until after the procedure
  3. 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
  4. Hypersensitivity to dextran sulfate, heparin, or ethylene oxide
  5. Adequate anticoagulation cannot be achieved due to severe hemophilia, severe hemorrhage diathesis, severe gastrointestinal ulcers, or are recipients of vitamin K antagonist medications
  6. 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 Note: Severe uncontrollable hypotension/hypertension indicates the cases with systolic and/or diastolic blood pressure ≤ 5th percentile for age, gender, and height.
  7. Cardiac impairments such as uncontrolled arrhythmia, unstable angina, decompensated congestive heart failure, or valvular disease
  8. Thyroid disease or liver abnormalities
  9. Unresolved systemic or local infection that could affect the clinical study outcomes

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): NCT04065438


Contacts
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Contact: Laleh Abedin, MD 6469846538 laleh.abedinzadeh@kaneka.com
Contact: Ayaka Kitamura Ayaka.Kitamura1@kaneka.co.jp

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         
Loma Linda University Hospital Recruiting
Loma Linda, California, United States, 92354
Contact: Amir Abdipour, MD         
Contact: Daisy Sekly       DSekly@llu.edu   
United States, Delaware
Nemours/Alfred I DuPont Hospital for Children Recruiting
Wilmington, Delaware, United States, 19803
Contact: Joshua J Zaritsly, MD    302-651-5527    joshua.zaritsky@nemours.org   
United States, Michigan
Helen DeVos Children's Hospital Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Alejandro Quiroga, MD         
United States, New York
Weill Cornell Medicine / NewYork-Presbyterian Recruiting
New York, New York, United States, 10065
Contact: Eduardo M Perelstein, MD         
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    330-543-0702    apokelsek@akronchildrens.org   
United States, South Carolina
Medical University of South Carolina Children's Hospital Recruiting
Charleston, South Carolina, United States, 29425
Contact: Katherine E Twombley, MD         
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Linda Walker    843-792-6109    walkerlp@musc.edu   
United States, Virginia
Children's Hospital of Richmond at VCU Recruiting
Richmond, Virginia, United States, 23298
Contact: Megan M Lo, MD         
Sponsors and Collaborators
Kaneka Pharma America LLC
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Responsible Party: Kaneka Pharma America LLC
ClinicalTrials.gov Identifier: NCT04065438    
Other Study ID Numbers: H170002
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Kaneka Pharma America LLC:
FSGS
Liposorber
Additional relevant MeSH terms:
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Glomerulosclerosis, Focal Segmental
Glomerulonephritis
Nephritis
Kidney Diseases
Urologic Diseases