RECRUITING

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

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Conditions

Focal Segmental Glomerulosclerosispediatric, renal transplantation, recurrence, drug-resistant

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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

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.

Official Title

Treatment of Drug-resistant Pediatric Primary Focal Segmental Glomerulosclerosis Using the Liposorber® LA-15 System

Quick Facts

Study Start:2015-05-03
Study Completion:2028-07-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02235857

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 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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:
  2. * 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);
  3. * 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);
  4. * Refractory or recurrent nephrotic syndrome in which standard therapy is contraindicated.
  1. * General Exclusion Criteria
  2. * Patient is greater than 21 years of age
  3. * 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)
  4. * 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.)
  5. * Unable or unwilling to comply with the follow-up schedule
  6. * Simultaneously participating in another investigational drug or device study
  7. * Body weight \< 15 kg (33.1 lbs)
  8. * Medical Exclusion Criteria
  9. * 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.)
  10. * 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
  11. * 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
  12. * Hypersensitivity to dextran sulfate, heparin, or ethylene oxide
  13. * Adequate anticoagulation cannot be achieved due to severe hemophilia, severe hemorrhage diathesis, severe gastrointestinal ulcers, or are recipients of vitamin K antagonist medications
  14. * 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
  15. * Cardiac impairments such as uncontrolled arrhyth¬mia, unstable angina, decompensated congestive heart failure, or valvular disease
  16. * Functional thyroid disease or liver abnormalities
  17. * 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

Principal Investigator

Jeffrey I Silberzweig, MD
PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University

Study Locations (Sites)

Loma Linda University Children's Hospital
Loma Linda, California, 92354
United States
Cedars Sinai Medical Center
Los Angeles, California, 90048
United States
Nemours/A.I. duPont Hospital for Children
Wilmington, Delaware, 19803
United States
Nemours Children's Health
Orlando, Florida, 32827
United States
Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
United States
University of Minnesota
Minneapolis, Minnesota, 55454
United States
Weill Cornell Medical Center / 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
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134
United States
Medical University of South Carolina Children's Hospital
Charleston, South Carolina, 29425
United States
Children's Hospital of Richmond at VCU
Richmond, Virginia, 23219
United States

Collaborators and Investigators

Sponsor: Kaneka Medical America LLC

  • Jeffrey I Silberzweig, MD, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

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 Date2015-05-03
Study Completion Date2028-07-03

Study Record Updates

Study Start Date2015-05-03
Study Completion Date2028-07-03

Terms related to this study

Keywords Provided by Researchers

  • pediatric, renal transplantation, recurrence, drug-resistant

Additional Relevant MeSH Terms

  • Focal Segmental Glomerulosclerosis