Post Approval Study of Liposorber LA-15 System for the Treatment of Focal Segmental Glomerulosclerosis in Children
Public ClinicalTrials.gov record NCT02235857. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Treatment of Drug-resistant Pediatric Primary Focal Segmental Glomerulosclerosis Using the Liposorber® LA-15 System
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02235857
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 35 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Up to 21 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 2, 2015
- Primary completion
- Sep 29, 2027
- Completion
- Sep 29, 2029
- Last update posted
- Aug 27, 2026
2015 – 2029
United States locations
- U.S. sites
- 12
- U.S. states
- 11
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Loma Linda University Children's Hospital | Loma Linda | California | 92354 | Recruiting |
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | Recruiting |
| Nemours/A.I. duPont Hospital for Children | Wilmington | Delaware | 19803 | Recruiting |
| Nemours Children's Health | Orlando | Florida | 32827 | Terminated |
| Helen DeVos Children's Hospital | Grand Rapids | Michigan | 49503 | Recruiting |
| University of Minnesota | Minneapolis | Minnesota | 55454 | Recruiting |
| Weill Cornell Medical Center / NewYork-Presbyterian | New York | New York | 10065 | Recruiting |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | Recruiting |
| Akron Children's Hospital | Akron | Ohio | 44308 | Recruiting |
| St. Christopher's Hospital for Children | Philadelphia | Pennsylvania | 19134 | Recruiting |
| Medical University of South Carolina Children's Hospital | Charleston | South Carolina | 29425 | Recruiting |
| Children's Hospital of Richmond at VCU | Richmond | Virginia | 23219 | Withdrawn |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02235857, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 27, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02235857 live on ClinicalTrials.gov.