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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 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.

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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.

Conditions Studied

Focal Segmental Glomerulosclerosis

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

FieldValue
Enrollment Target 35 participants
Start Date 2020-01-01
Est. Completion 2028-06-01
Phase NA

Sponsor

Kaneka Medical America

5 total trials

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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, 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 is the first listed.

NCT04065438 reports 10 study locations spanning 8 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.