Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Post Approval Study for Treatment of Drug-resistant Adult and Pediatric Primary FSGS Using the LIPOSORBER® LA-15 System
NCT04065438 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DEVICE LIPOSORBER® LA-15
Study Locations (10)
California
- Loma Linda University Children's Hospital — Loma Linda
- Loma Linda University Hospital — Loma Linda
South Carolina
- Medical University of South Carolina Children's Hospital — Charleston
- Medical University of South Carolina — Charleston
Delaware
- Nemours/Alfred I DuPont Hospital for Children — Wilmington
Michigan
- Helen DeVos Children's Hospital — Grand Rapids
New York
- Weill Cornell Medicine / NewYork-Presbyterian — New York
North Carolina
- University of North Carolina — Chapel Hill
Ohio
- Akron Children's Hospital — Akron
Virginia
- Children's Hospital of Richmond at VCU — Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2020-01-01 |
| Est. Completion | 2028-06-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04065438
The ClinicalTrials.gov registry entry for NCT04065438 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kaneka Medical America, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04065438 reports 10 study locations spanning 8 distinct geographic areas — top geographies include California, South Carolina, Delaware. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04065438 about?
NCT04065438 is a clinical study titled "Post Approval Study for Treatment of Drug-resistant Adult and Pediatric Primary FSGS Using the LIPOSORBER® LA-15 System". 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, includin...
What is the current status of trial NCT04065438?
This trial is currently recruiting. It is a NA study. The enrollment target is 35 participants. The study started on 2020-01-01. Estimated completion is 2028-06-01.
What conditions does trial NCT04065438 study?
This clinical trial studies the following conditions: Focal Segmental Glomerulosclerosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04065438?
The interventions under investigation include: LIPOSORBER® LA-15 (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04065438?
This trial is sponsored by Kaneka Medical America, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04065438 being conducted?
This trial has 10 study locations across California, Delaware, Michigan, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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