Actively Recruiting
taVNS for FRNS in Children
Led by Northwell Health · Updated on 2026-04-15
30
Participants Needed
2
Research Sites
238 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 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.
CONDITIONS
Official Title
taVNS for FRNS in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 3 to 17 years
- Diagnosed with frequently relapsing nephrotic syndrome (FRNS)
- Estimated glomerular filtration rate (eGFR) of 30 ml/min/1.73 m2 or higher
- Diagnosis of minimal change disease (MCD) or focal segmental glomerulosclerosis (FSGS) by clinical evaluation or biopsy
- Steroid sensitive nephrotic syndrome with prior remission within 4 weeks of steroid therapy
- In remission at enrollment with urine protein creatinine ratio (UPC) less than 0.2 or negative dipstick for 3 consecutive days
- Parent or guardian provides informed consent; minors aged 7 years or older provide assent
You will not qualify if you...
- Secondary forms of nephrotic syndrome
- Steroid resistant nephrotic syndrome (SRNS)
- Steroid dependent nephrotic syndrome (relapse within 14 days of stopping steroids or relapse while on steroids)
- Use of steroids within 14 days before enrollment
- Current use of any standing immunosuppressive medications (previous exposure longer than 2 months allowed)
- Known inflammatory conditions such as systemic lupus erythematosus
- History of heart disease including arrhythmias or structural/functional abnormalities
- Presence of implantable electronic devices
- Pregnancy
- Likely non-compliance with study schedules or procedures as judged by the investigator
AI-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, 19102
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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