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NCT04065438 · ClinicalTrials.gov registry record · NA
Post Approval Study for Treatment of Drug-resistant Adult and Pediatric Primary FSGS Using the LIPOSORBER® LA-15 System
A NA study of Focal Segmental Glomerulosclerosis, sponsored by Kaneka Medical America.
- Recruiting
- Registry status
- NA
- Development phase
- 35
- Enrollment target
- 10
- Study locations
NCT04065438: Recruiting NA study of Focal Segmental Glomerulosclerosis, sponsored by Kaneka Medical America.
NCT04065438 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 10 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04065438, 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
- 10
- Study locations
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.
Primary Outcome
The primary probable benefit endpoint will be assessed by calculating the percent reduction in Up/c values at screening and at 1 month after the final apheresis.
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 |
What NCT04065438 shows while recruiting
NCT04065438 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 235-participant average among 19 other Focal Segmental Glomerulosclerosis trials with a reported enrollment target (85% lower).
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.
NCT04065438 lists 10 locations in 8 states (California, South Carolina, Delaware).
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.
What interventions are being tested in trial NCT04065438?
The interventions under investigation include: LIPOSORBER® LA-15 (DEVICE).
Who is sponsoring clinical trial NCT04065438?
This trial is sponsored by Kaneka Medical America, which has 5 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Focal Segmental Glomerulosclerosis
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Where NCT04065438's enrollment target sits among peer trials
35 12th of 19 higher than 7 of 19 other Focal Segmental Glomerulosclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Focal Segmental Glomerulosclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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-
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