Vagus nerve stimulation for treating nephrotic syndrome in children
Official title: A Pilot Randomized Clinical Trial of Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Frequently Relapsing Nephrotic Syndrome in Children
Run by Northwell Health · NCT05588063 · Data updated 2026-11-12
This study is testing whether a new treatment using vagus nerve stimulation can help children aged 3 to 17 with nephrotic syndrome feel better and reduce their symptoms.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 3 Years to 17 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Northwell Health Academic / other |
| Locations | 2 sites (New Hyde Park, New York and 1 other locations) |
| Status | Recruiting |
| Started | January 5, 2023 |
| Main results expected | March 1, 2027 |
| Study ends | August 1, 2027 |
| Registry record updated | April 15, 2026 |
| Trial ID | NCT05588063 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 3 to 17 with frequently relapsing nephrotic syndrome who are currently in remission.
✕Probably not a fit
Patients with secondary forms of nephrotic syndrome or those who are steroid-dependent may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the use of transcutaneous auricular vagus nerve stimulation (taVNS) as a novel treatment for children aged 3 to 17 with frequently relapsing nephrotic syndrome. The study is designed as a double-blinded, randomized, placebo-controlled trial, enrolling 30 participants who will receive either active taVNS therapy or a sham treatment for 26 weeks. Participants will monitor their heart rate and urine results, with regular in-person and virtual follow-up visits to assess treatment response and tolerability. The goal is to evaluate the feasibility of taVNS and gather preliminary data on its effectiveness in managing nephrotic syndrome in pediatric patients.
Why it matters
Potential benefit: If successful, this treatment could provide a safer and more effective alternative to prolonged steroid use for children with nephrotic syndrome.
How similar studies have gone: While the use of taVNS is a relatively novel approach in this context, previous studies have shown promise in using vagus nerve stimulation for other chronic immune-mediated conditions.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * FRNS * Age 3-17 years * Glomerular filtration rate (eGFR) ≥30 ml/min/1.73 m2 * Minimal change disease (MCD) or focal segmental glomerulosclerosis (FSGS) diagnosis (clinical diagnosis or per biopsy) * Steroid sensitive nephrotic syndrome (prior history of remission within 4 weeks of steroid therapy) * In remission at time of enrollment (remission defined as UPC \<0.2 or negative dipstick for 3 consecutive days) * Informed consent from the parent or guardian and assent from a minor of ≥ 7. years Exclusion Criteria: * Secondary forms of nephrotic syndrome * SRNS * Steroid dependent nephrotic syndrome (relapse within 14 days of stopping steroids or relapse while on steroids) * Exposure to steroids within 14 days of enrollment * Receiving any standing immunosuppression (previous exposure \> 2 months allowed and/or B cell repletion) * Any known inflammatory condition (e.g. systemic lupus erythematosis) * History of cardiac disease (arrhythmias, structural/functional abnormalities) * Implantable electronic devices * Pregnancy * Participants/guardians or participants who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures
Where it's running
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Cohen Children's Medical Center
New Hyde Park, New York, United States Recruiting -
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States Recruiting
Study contacts
- Study coordinator: Christine B Sethna, MD, EdM
- Email: csethna@northwell.edu
- Phone: 718-470-3491
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Using vagus nerve stimulation to treat nephrotic syndrome in children
This study is testing if a new type of nerve stimulation can help children with steroid-resistant nephrotic syndrome feel better over 26 weeks.
-
NEPTUNE Match: Personalized matching of patients to kidney treatment options
This project will try a system that matches people in the NEPTUNE cohort who have nephrotic syndromes or related kidney diseases with suitable clinical trials and shares those matches with patients and their doctors.
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Testing ManNAc for treating kidney disease FSGS
This study is testing if a new oral treatment called ManNAc can help adults with kidney disease FSGS by reducing protein levels in their urine and checking how safe it is over 12 weeks.
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Observational study on kidney transplant recurrence in FSGS and MCD
This study is looking at patients with kidney diseases called FSGS and MCD who have had or will have a kidney transplant to see how often these diseases come back afterward.
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Exploring experiences of patients and parents dealing with swelling from Nephrotic Syndrome
This study talks to patients and parents about their experiences with swelling from Nephrotic Syndrome to help create better ways to measure how new treatments work.
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Treatment of pediatric kidney diseases with Sparsentan
This study is testing if a new oral medication called Sparsentan can help children aged 1 to 18 with certain kidney diseases feel better and improve their condition over two years.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.