Actively Recruiting
A Pilot Trial of taVNS for SRNS in Children (kidNEY-VNS)
Led by Northwell Health · Updated on 2026-04-17
10
Participants Needed
2
Research Sites
253 weeks
Total Duration
On this page
Sponsors
N
Northwell Health
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Pilot Trial of taVNS for SRNS in Children (kidNEY-VNS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 3 to 17 years
- Steroid resistant nephrotic syndrome with no remission after 4 weeks of standard steroid therapy
- Estimated glomerular filtration rate (eGFR) of 30 ml/min/1.73 m2 or higher
- Diagnosis of Minimal Change Disease or Focal Segmental Glomerulosclerosis confirmed by biopsy
- Urine protein:creatinine ratio greater than 1.0
- Stable immunosuppressant and ACE inhibitor or angiotensin receptor blocker treatment for at least three months
- Evidence of B cell repletion for those previously treated with rituximab
- Informed consent from parent or guardian and assent from minors aged 7 years or older
- Ability to follow the study protocol as judged by the investigator
You will not qualify if you...
- Secondary causes of nephrotic syndrome such as genetic, congenital, or infectious causes
- Steroid sensitive nephrotic syndrome
- Known genetic defects causing nephrotic syndrome (e.g., NPHS2, NPHS1, PLCE1, WT1)
- Any known inflammatory condition
- History of cardiac disease including arrhythmias or structural heart abnormalities
- Presence of implantable electronic devices like pacemakers, defibrillators, hearing aids, cochlear implants, or deep brain stimulators
- Chronic rash or skin breakdown on the left ear at the stimulation site
- Pregnancy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Cohen Children's Medical Center
New Hyde Park, New York, United States, 11040
Actively Recruiting
2
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
C
Christine B Sethna, MD, EdM
CONTACT
S
Suzanne Vento, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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