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

Launched by NORTHWELL HEALTH · Oct 13, 2022

Keywords

ClinConnect Summary

The kidNEY-VNS trial is studying a new treatment for children with steroid-resistant nephrotic syndrome (SRNS), a kidney condition that does not improve with standard steroid medications. This trial is exploring the use of a technique called transcutaneous auricular vagus nerve stimulation (taVNS), which involves gently stimulating a nerve in the ear to help improve the immune response and reduce inflammation. Researchers want to find out if this method is safe and effective for children aged 3 to 17 with specific types of SRNS, such as Minimal Change Disease or Focal Segmental Glomerulosclerosis.

To participate, children must have been diagnosed with SRNS and have not responded to traditional steroid therapy. They should also have stable kidney function and have been on a consistent treatment plan for at least three months. Participants will receive either the taVNS treatment or a placebo (sham therapy), and their response will be monitored over time. This trial offers a chance to be part of an innovative approach to treating a challenging condition, and parents will need to give consent while younger participants will provide their agreement as well.

Gender

ALL

Eligibility criteria

• 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