Post Approval Study for Treatment of Drug-resistant Adult and Pediatric Primary FSGS Using the LIPOSORBER® LA-15 System

Description

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 ≥ 45 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.

Conditions

Focal Segmental Glomerulosclerosis

Talk to us

Study Overview

On this page

Study Details

Study overview

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 ≥ 45 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.

Treatment of Drug-resistant Adult and Pediatrc Primary Focal Segmental Glomerulosclerosis and Post -Transplant Recurrence Using the LIPOSORBER® LA-15 System

Post Approval Study for Treatment of Drug-resistant Adult and Pediatric Primary FSGS Using the LIPOSORBER® LA-15 System

Condition
Focal Segmental Glomerulosclerosis
Intervention / Treatment

-

Contacts and Locations

Loma Linda

Loma Linda University Children's Hospital, Loma Linda, California, United States, 92354

Loma Linda

Loma Linda University Hospital, Loma Linda, California, United States, 92354

Wilmington

Nemours/Alfred I DuPont Hospital for Children, Wilmington, Delaware, United States, 19803

Grand Rapids

Helen DeVos Children's Hospital, Grand Rapids, Michigan, United States, 49503

New York

Weill Cornell Medicine / NewYork-Presbyterian, New York, New York, United States, 10065

Chapel Hill

University of North Carolina, Chapel Hill, North Carolina, United States, 27599

Akron

Akron Children's Hospital, Akron, Ohio, United States, 44308

Charleston

Medical University of South Carolina Children's Hospital, Charleston, South Carolina, United States, 29425

Charleston

Medical University of South Carolina, Charleston, South Carolina, United States, 29425

Richmond

Children's Hospital of Richmond at VCU, Richmond, Virginia, United States, 23298

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 \< 15 kg (33.1 lbs)
  • 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. Functional thyroid disease or liver abnormalities
  • 9. Unresolved systemic or local infection that could affect the clinical study outcomes

Ages Eligible for Study

to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Kaneka Medical America LLC,

Study Record Dates

2028-06-01