NCT05588063 · Northwell Health
taVNS for FRNS in Children
(kidNEY-VNS)
What this study is about
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 effectiveness of these medications, there is an urgent need to identify novel and safe therapies to treat nephrotic syndrome in children.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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
- Participants/guardians or participants who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures
Where
- New Hyde Park, New York
- Philadelphia, Pennsylvania
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 15, 2026 · Source of record for eligibility and locations