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

Part of paid clinical trials in Loma Linda, California.

Sponsor
Kaneka Medical America LLC
Study ID
NCT02235857
Status
Recruiting
Apply to this trial

Conditions

  • Focal Segmental Glomerulosclerosis

Eligibility Criteria

Sex
ALL
Age
N/A - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • LIPOSORBER® LA-15 System — DEVICE
    LIPOSORBER® LA-15 System is an extracorporeal blood purification system. Approximately 3 to 4 L of plasma is treated in a single treatment session and it takes 2 to 3 hours. Recommended frequency of the treatment is twice weekly for 3 weeks followed by once weekly for 6 weeks, thus it takes 9 weeks for a total of 12 treatment sessions.

Study Details

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.

Key Dates

Start date
May 3, 2015
Status verified
Oct 2024
Primary completion
May 3, 2026
Completion
Jul 3, 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

The percent of patients who show complete or partial remission [ Time Frame: 1 month after the final treatment ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
Loma Linda University Children's HospitalLoma LindaCalifornia92354
Cheryl P Sanchez-Kazi, MD
909-651-1904
Cedars Sinai Medical CenterLos AngelesCalifornia90048
Ananth S Karumanchi
[email protected]
310-423-7608
Nemours/A.I. duPont Hospital for ChildrenWilmingtonDelaware19803
Joshua Zaritsky, MD PhD
[email protected]
302-651-5527
Nemours Children's HealthOrlandoFlorida32827-
Helen DeVos Children's HospitalGrand RapidsMichigan49503
Alejandro Quiroga, MD
616-267-2400
University of MinnesotaMinneapolisMinnesota55454
Michelle Rheault, MD
[email protected]
612-626-2922
Weill Cornell Medical Center / NewYork-PresbyterianNew YorkNew York10065
Eduardo M Perelstein, MD
[email protected]
646-962-4324
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]
330-543-8950
Ann Pokelsek, BSN, RN,
[email protected]
330-543-0702
St. Christopher's Hospital for ChildrenPhiladelphiaPennsylvania19134
Joshua J Zaritsky, MD
215-427-5190
Medical University of South Carolina Children's HospitalCharlestonSouth Carolina29425
Katherine E Twombley, MD
[email protected]
843-792-8904
Children's Hospital of Richmond at VCURichmondVirginia23219-

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Loma Linda University Children's Hospital· Loma Linda, CACedars Sinai Medical Center· Los Angeles, CANemours/A.I. duPont Hospital for Children· Wilmington, DENemours Children's Health· Orlando, FLHelen DeVos Children's Hospital· Grand Rapids, MIUniversity of Minnesota· Minneapolis, MN

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