RecruitingNot Applicable

A Pilot Trial of taVNS for SRNS in Children (kidNEY-VNS)

United States10 participantsStarted 2022-09-19

Plain-language summary

Children with steroid resistant nephrotic syndrome (SRNS) are exposed to prolonged courses of 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 noninvasively 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.

Who can participate

Age range

3 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Success of Pilot Trial

Timeframe: Baseline to 26 weeks

Trial details

NCT IDNCT05583942

SponsorNorthwell Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03-01

Contact for this trial

Christine B Sethna, MD, EdM

718-470-3491 csethna@northwell.edu

View on ClinicalTrials.gov More Nephrotic Syndrome in Children trials