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NCT02235857 · ClinicalTrials.gov registry record · NA
Post Approval Study of Liposorber LA-15 System for the Treatment of Focal Segmental Glomerulosclerosis in Children
A NA study of Focal Segmental Glomerulosclerosis, sponsored by Kaneka Medical America.
- Recruiting
- Registry status
- NA
- Development phase
- 35
- Enrollment target
- 12
- Study locations
NCT02235857 is a NA study of Focal Segmental Glomerulosclerosis that is actively recruiting participants, run by Kaneka Medical America. The registered enrollment target is 35 participants, below the 235-participant average among 19 other Focal Segmental Glomerulosclerosis trials with a reported enrollment target (85% lower). The trial reports 12 study locations across 11 states.
The verdict
NCT02235857, a NA study of Focal Segmental Glomerulosclerosis, is actively recruiting participants, sponsored by Kaneka Medical America.
- RECRUITING
- Registry status
- NA
- Development phase
- 35 participants
- Enrollment target
- 12
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DEVICE LIPOSORBER® LA-15 System
Study Locations (12)
California
- Loma Linda University Children's Hospital - Loma Linda
- Cedars Sinai Medical Center - Los Angeles
Delaware
- Nemours/A.I. duPont Hospital for Children - Wilmington
Florida
- Nemours Children's Health - Orlando
Michigan
- Helen DeVos Children's Hospital - Grand Rapids
Minnesota
- University of Minnesota - Minneapolis
New York
- Weill Cornell Medical Center / NewYork-Presbyterian - New York
North Carolina
- University of North Carolina - Chapel Hill
Ohio
- Akron Children's Hospital - Akron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2015-05-03 |
| Est. Completion | 2028-07-03 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02235857
The ClinicalTrials.gov registry entry for NCT02235857 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 235-participant average among 19 other Focal Segmental Glomerulosclerosis trials with a reported enrollment target (85% lower). The listed sponsor is Kaneka Medical America, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Focal Segmental Glomerulosclerosis appearing as the primary indexed condition, and to 1 intervention - of which LIPOSORBER® LA-15 System is the first listed.
NCT02235857 reports 12 study locations spanning 11 distinct geographic areas - top geographies include California, Delaware, Florida.
Frequently Asked Questions
What is clinical trial NCT02235857 about?
NCT02235857 is a clinical study titled "Post Approval Study of Liposorber LA-15 System for the Treatment of Focal Segmental Glomerulosclerosis in Children". 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 dysl...
What is the current status of trial NCT02235857?
This trial is currently recruiting. It is a NA study. The enrollment target is 35 participants. The study started on 2015-05-03. Estimated completion is 2028-07-03.
What conditions does trial NCT02235857 study?
This clinical trial studies the following conditions: Focal Segmental Glomerulosclerosis.
What interventions are being tested in trial NCT02235857?
The interventions under investigation include: LIPOSORBER® LA-15 System (DEVICE).
Who is sponsoring clinical trial NCT02235857?
This trial is sponsored by Kaneka Medical America, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02235857 being conducted?
This trial has 12 study locations across California, Delaware, Florida, Michigan, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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