A Pilot Trial of taVNS for SRNS in Children (kidNEY-VNS)
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Nephrotic Syndrome in Children, Minimal Change Disease, Focal Segmental Glomerulosclerosis
In brief
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.
Key facts
- Study ID
- NCT05583942
- Run by
- Northwell Health
- People needed
- 10
- Starts
- 2022-09-19
- Expected to finish
- 2027-08-01
- Last updated by the study team
- 2026-04-17
Who can join
Age: 3 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Cohen Children's Medical Center — New Hyde Park, New York, United States (enrolling)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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