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

Overview

About this study

The purpose of this study is to 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.

 

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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) ≥ 45 ml/min/1.73 m2 .
    • The patient is post renal transplantation.  

Exclusion Criteria: 

  • Patient is greater than 75 years of age at the start of the treatment period or less than 22.
  • The patient is unwilling or unable to sign and date the informed consent.
  • 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. 
  • 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.,  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.
    • Note: Severe uncontrollable hypotension/hypertension  indicates the cases with systolic and/or diastolic blood pressure ≤ 5th percentile for  age, gender, and height.
  • Cardiac impairments such as uncontrolled arrhythmia, unstable angina, decompensated  congestive heart failure, or valvular disease.
  • Thyroid disease or liver abnormalities.
  • Unresolved systemic or local infection that could affect the clinical study outcomes.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Hatem Amer, M.D.

Open for enrollment

Contact information:

Julie Gecox Hanson CCRP

(507) 293-6592

Gecox.Julie@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Hani Wadei, M.D.

Contact us for the latest status

Contact information:

Katelyn Register M.S., C.C.R.C.

Register.Katelyn@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Girish Mour, M.B.B.S., M.D.

Contact us for the latest status

Contact information:

Leena Abraham R.N.

(480) 342-6750

Abraham.Leena@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20490568

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