Intervention Group for Nephrotic Syndrome

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Nephrotic Syndrome+2 MoreTranscutaneous auricular vagus nerve stimulation - Device
Eligibility
3 - 17
All Sexes
What conditions do you have?
Select

Study Summary

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.

Eligible Conditions
  • Nephrotic Syndrome
  • Focal Segmental Glomerulosclerosis

Treatment Effectiveness

Study Objectives

1 Primary · 14 Secondary · Reporting Duration: Baseline through 26 weeks

Hour 2
Whole monocyte stimulation assay
Baseline through 26 weeks
Adverse events
Anti-nephrin antibodies
Cytokine
Drop out rate
Estimates of Variance for proportion with nephrotic syndrome relapse
Estimates of Variance for time to achieve remission once a relapse occurs
Estimates of Variance for time to nephrotic syndrome relapse
Incidence of withdrawal due to adverse events
Proof-of-Concept Decision Criteria using relative risk for relapse
Rate of completion of study
Recruitment rate
Success of Pilot Trial
Successful double-blinding
Treatment adherence from home logs

Trial Safety

Trial Design

2 Treatment Groups

Intervention Group
1 of 2
Sham Group
1 of 2

Experimental Treatment

Non-Treatment Group

30 Total Participants · 2 Treatment Groups

Primary Treatment: Intervention Group · Has Placebo Group · N/A

Intervention Group
Device
Experimental Group · 1 Intervention: Transcutaneous auricular vagus nerve stimulation · Intervention Types: Device
Sham Group
Device
ShamComparator Group · 1 Intervention: Sham device · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline through 26 weeks

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,147 Previous Clinical Trials
4,074,618 Total Patients Enrolled
14 Trials studying Nephrotic Syndrome
6,398 Patients Enrolled for Nephrotic Syndrome
Northwell HealthLead Sponsor
425 Previous Clinical Trials
493,500 Total Patients Enrolled
3 Trials studying Nephrotic Syndrome
21 Patients Enrolled for Nephrotic Syndrome

Eligibility Criteria

Age 3 - 17 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are between the ages of 3 and 17 years old.
Your glomerular filtration rate is at least 30 ml/min/1.73 m2.
You have been diagnosed with either Minimal Change Disease or Focal Segmental Glomerulosclerosis, either through clinical diagnosis or via biopsy.
You have previously experienced remission of nephrotic syndrome within four weeks following a course of steroid treatment.
You are in remission based on urine protein creatinine levels or negative dipstick results for three consecutive days.
You must obtain authorization from a parent or guardian, as well as agreement from someone aged 7 years old or older.