Using vagus nerve stimulation to treat nephrotic syndrome in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot trial investigates the use of transcutaneous auricular vagus nerve stimulation (taVNS) as a novel treatment for children aged 3 to 17 with steroid-resistant nephrotic syndrome (SRNS). The study will randomly assign participants to receive either active taVNS therapy or a sham treatment over a 26-week period, with daily sessions lasting five minutes. Participants will be monitored for heart rate and urine results, with follow-up visits scheduled throughout the trial to assess treatment feasibility and response. The goal is to establish proof-of-concept for taVNS in this patient population and gather data on its potential effectiveness.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Steroid Resistant Nephrotic Syndrome- defined as lack of remission after 4 weeks of therapy of prednisolone/prednisone at standard dose1
* Age 3-17 years
* eGFR ≥30 ml/min/1.73 m2 (by modified Schwartz formula)
* MCD or FSGS diagnosis (per biopsy)
* Urine protein:creatinine (UPC) greater than 1.0
* Stable immunosuppression and ACE inhibitor/angiotensin receptor blocker treatment regimen for at least three months
* Evidence of B cell repletion for those exposed to rituximab
* Informed consent from the parent or guardian and assent from a minor of ≥ 7 years
* Ability to comply with the study protocol, in the investigator's judgment

Exclusion Criteria:

* Secondary causes of nephrotic syndrome (e.g. genetic, congenital, infectious)
* Steroid sensitive nephrotic syndrome
* History of genetic defects known to directly cause nephrotic syndrome (i.e., NPHS2 \[podocin\], NPHS1 \[nephrin\], PLCE1, WT1, or other known genetic cause)
* Any known inflammatory condition
* History of cardiac disease (arrhythmias, structural/functional abnormalities)
* Implantable electronic devices (pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators)
* Chronic rash or skin breakdown of the left ear at the cymba concha
* Pregnancy

Where it's running

• 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.

• Vagus nerve stimulation for treating nephrotic syndrome in children

  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.

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• Testing ManNAc for treating kidney disease FSGS

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  Recruiting Phase 2 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT06664814

• Observational study on kidney transplant recurrence in FSGS and MCD

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• Exploring experiences of patients and parents dealing with swelling from Nephrotic Syndrome

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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.

  Recruiting at 38 sites Phase 2 Travere Therapeutics, Inc. · Los Angeles, California and 46 other locations · NCT05003986

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.