taVNS for FRNS in Children (NCT05588063) | Clinical Trial Compass
RecruitingNot Applicable
taVNS for FRNS in Children
United States30 participantsStarted 2023-01-05
Plain-language 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.
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:
* 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
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.