taVNS for FRNS in Children

Launched by NORTHWELL HEALTH · Oct 13, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach called transcutaneous auricular vagus nerve stimulation (taVNS) for children who have frequently relapsing nephrotic syndrome (FRNS). This condition can cause kidney problems and often requires long-term use of steroids and other medications, which can have unwanted side effects. The study aims to see if taVNS can safely help manage nephrotic syndrome in children and looks at its effects on inflammation in the body.

To be eligible for the trial, children aged 3 to 17 years old with a specific type of nephrotic syndrome, such as minimal change disease or focal segmental glomerulosclerosis, can participate if they are currently in remission and have been responsive to steroids in the past. Participants will receive either the taVNS treatment or a placebo (a treatment that looks the same but has no active ingredients) to see how well it works. The trial is currently recruiting participants, and it’s important for parents or guardians to provide consent for their child to take part. This study could help pave the way for safer treatments for nephrotic syndrome in children.

Gender

ALL

Eligibility 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