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

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

• or

• • The patient is post renal transplantation.

Locations
United States
California
Loma Linda University Children's Hospital
RECRUITING
Loma Linda
Loma Linda University Hospital
RECRUITING
Loma Linda
Delaware
Nemours/Alfred I DuPont Hospital for Children
RECRUITING
Wilmington
Michigan
Helen DeVos Children's Hospital
RECRUITING
Grand Rapids
North Carolina
University of North Carolina
RECRUITING
Chapel Hill
New York
Weill Cornell Medicine / NewYork-Presbyterian
RECRUITING
New York
Ohio
Akron Children's Hospital
RECRUITING
Akron
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Medical University of South Carolina Children's Hospital
RECRUITING
Charleston
Virginia
Children's Hospital of Richmond at VCU
RECRUITING
Richmond
Contact Information
Primary
Ayaka Kitamura
Ayaka.Kitamura1@kaneka.co.jp
+81-74431813933
Time Frame
Start Date: 2020-01-01
Estimated Completion Date: 2028-06-01
Participants
Target number of participants: 35
Treatments
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.
Sponsors
Leads: Kaneka Medical America LLC

This content was sourced from clinicaltrials.gov