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NCT05588063 · ClinicalTrials.gov registry record · NA
taVNS for FRNS in Children
A NA study of Focal Segmental Glomerulosclerosis and Minimal Change Disease, sponsored by Northwell Health.
- Recruiting
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 2
- Study locations
NCT05588063: Recruiting NA study of Focal Segmental Glomerulosclerosis and Minimal Change Disease, sponsored by Northwell Health.
NCT05588063 is a NA study of Focal Segmental Glomerulosclerosis and Minimal Change Disease that is actively recruiting participants, run by Northwell Health. The registered enrollment target is 30 participants, below the 235-participant average among 19 other Focal Segmental Glomerulosclerosis trials with a reported enrollment target (87% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05588063, a NA study of Focal Segmental Glomerulosclerosis and Minimal Change Disease, is actively recruiting participants, sponsored by Northwell Health.
- RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 2
- Study locations
Study Summary
Children with frequently relapsing nephrotic syndrome (FRNS) are exposed to prolonged courses of steroids and other immunosuppressant medications. Given the adverse side effect profiles and variable efficacy of these medications, there is an urgent need to identify novel and safe therapies to treat nephrotic syndrome in children. Stimulation of the vagus nerve, which can be activated non invasively by transcutaneous auricular vagus nerve stimulation (taVNS), has immunomodulatory effects mediated by the inflammatory reflex and spleen. taVNS has become a therapy of interest for treating chronic immune mediated illnesses. The aims of the study are (1) To determine the feasibility of protocol implementation and tolerability of taVNS in the treatment of nephrotic syndrome in children (2) To establish proof-of-concept and generate statistical estimates of variance parameters and effect sizes for treatment response outcomes in children with nephrotic syndrome randomized to taVNS therapy compared with sham therapy (3) To investigate the effects of taVNS on inflammatory markers in children with nephrotic syndrome.
Primary Outcome
1. Unsuccessful, main study not practicable (1) None of the benchmarks are met, or (2) One or more of the benchmarks are not met and there is low likelihood of reaching benchmarks even with protocol modifications or (3) Serious adverse events related to the treatment. 2. Probable Success main study practicable with modifications to protocol. One or more of the benchmarks are not met, but there is a high likelihood that the benchmark can be met with protocol modifications. 3. Successful main stud
Conditions Studied
Interventions
- DEVICE Sham device
- DEVICE Transcutaneous auricular vagus nerve stimulation
Study Locations (2)
New York
- Cohen Children's Medical Center - New Hyde Park
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-01-05 |
| Est. Completion | 2025-08-01 |
| Phase | NA |
What NCT05588063 shows while recruiting
NCT05588063 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 235-participant average among 19 other Focal Segmental Glomerulosclerosis trials with a reported enrollment target (87% lower).
The record links to 3 conditions, with Focal Segmental Glomerulosclerosis appearing as the primary indexed condition, and to 2 interventions - of which Sham device is the first listed.
NCT05588063 reports a single indexed study location in New York, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05588063 about?
NCT05588063 is a clinical study titled "taVNS for FRNS in Children". Children with frequently relapsing nephrotic syndrome (FRNS) are exposed to prolonged courses of steroids and other immunosuppressant medications. Given the adverse side effect profiles and variable efficacy of these medications, there is an urgent need to identify novel and safe therapies to treat ...
What is the current status of trial NCT05588063?
This trial is currently recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2023-01-05. Estimated completion is 2025-08-01.
What conditions does trial NCT05588063 study?
This clinical trial studies the following conditions: Focal Segmental Glomerulosclerosis, Minimal Change Disease, Nephrotic Syndrome in Children.
What interventions are being tested in trial NCT05588063?
The interventions under investigation include: Sham device (DEVICE), Transcutaneous auricular vagus nerve stimulation (DEVICE).
Who is sponsoring clinical trial NCT05588063?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05588063 being conducted?
This trial has 2 study locations across New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05588063's enrollment target sits among peer trials
30 14th of 19 higher than 4 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.
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