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

Part of paid clinical trials in Loma Linda, California.

Sponsor
Kaneka Medical America LLC
Study ID
NCT04065438
Status
Recruiting
Apply to this trial

Conditions

  • Focal Segmental Glomerulosclerosis

Eligibility Criteria

Sex
ALL
Age
N/A - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • LIPOSORBER® LA-15 — DEVICE
    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).

Study Details

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.

Key Dates

Start date
Jan 1, 2020
Status verified
Oct 2024
Primary completion
Apr 1, 2026
Completion
Jun 1, 2028

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

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. ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Loma Linda University Children's HospitalLoma LindaCalifornia92354
Cheryl P Sanchez-Kazi, MD
Loma Linda University HospitalLoma LindaCalifornia92354
Amir Abdipour, MD
Daisy Sekly
[email protected]
Nemours/Alfred I DuPont Hospital for ChildrenWilmingtonDelaware19803
Joshua J Zaritsly, MD
[email protected]
302-651-5527
Helen DeVos Children's HospitalGrand RapidsMichigan49503
Alejandro Quiroga, MD
Weill Cornell Medicine / NewYork-PresbyterianNew YorkNew York10065
Eduardo M Perelstein, MD
University of North CarolinaChapel HillNorth Carolina27599
Koyal Jain, MD
Anne Froment
[email protected]
(919) 445-2622
Akron Children's HospitalAkronOhio44308
Rupesh Raina, MD
[email protected]
330-543-0702
Medical University of South CarolinaCharlestonSouth Carolina29425
Linda Walker
[email protected]
843-792-6109
Medical University of South Carolina Children's HospitalCharlestonSouth Carolina29425
Katherine E Twombley, MD
Children's Hospital of Richmond at VCURichmondVirginia23298
Megan M Lo, MD

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By research site
Loma Linda University Children's Hospital· Loma Linda, CALoma Linda University Hospital· Loma Linda, CANemours/Alfred I DuPont Hospital for Children· Wilmington, DEHelen DeVos Children's Hospital· Grand Rapids, MIWeill Cornell Medicine / NewYork-Presbyterian· New York, NYUniversity of North Carolina· Chapel Hill, NC

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