RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2020-01-01
Study Completion:2028-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04065438

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.

Ages Eligible for Study:Not specified to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 1. Patient is greater than 75 years of age at the start of the treatment period or less than 22
  2. 2. The patient is unwilling or unable to sign and date the informed consent
  3. 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. 4. Unable or unwilling to comply with the follow-up schedule
  5. 5. Simultaneously participating in another investigational drug or device study
  6. 6. Body weight \< 15 kg (33.1 lbs)
  7. 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.)
  8. 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
  9. 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
  10. 4. Hypersensitivity to dextran sulfate, heparin, or ethylene oxide
  11. 5. Adequate anticoagulation cannot be achieved due to severe hemophilia, severe hemorrhage diathesis, severe gastrointestinal ulcers, or are recipients of vitamin K antagonist medications
  12. 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.
  13. 7. Cardiac impairments such as uncontrolled arrhythmia, unstable angina, decompensated congestive heart failure, or valvular disease
  14. 8. Functional thyroid disease or liver abnormalities
  15. 9. Unresolved systemic or local infection that could affect the clinical study outcomes

Contacts and Locations

Study Contact

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

Study Locations (Sites)

Loma Linda University Children's Hospital
Loma Linda, California, 92354
United States
Loma Linda University Hospital
Loma Linda, California, 92354
United States
Nemours/Alfred I DuPont Hospital for Children
Wilmington, Delaware, 19803
United States
Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
United States
Weill Cornell Medicine / NewYork-Presbyterian
New York, New York, 10065
United States
University of North Carolina
Chapel Hill, North Carolina, 27599
United States
Akron Children's Hospital
Akron, Ohio, 44308
United States
Medical University of South Carolina Children's Hospital
Charleston, South Carolina, 29425
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Children's Hospital of Richmond at VCU
Richmond, Virginia, 23298
United States

Collaborators and Investigators

Sponsor: Kaneka Medical America LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-01-01
Study Completion Date2028-06-01

Study Record Updates

Study Start Date2020-01-01
Study Completion Date2028-06-01

Terms related to this study

Keywords Provided by Researchers

  • FSGS
  • Liposorber

Additional Relevant MeSH Terms

  • Focal Segmental Glomerulosclerosis