Intervention Group for Nephrotic Syndrome

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

Study Summary

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.

Eligible Conditions
  • Nephrotic Syndrome
  • Focal Segmental Glomerulosclerosis

Treatment Effectiveness

Study Objectives

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

0 hours, 2 hours
Whole blood monocyte stimulation test
Baseline to 26 weeks
Adverse events
Anti-nephrin antibodies
Cytokine
Effect size for change in Change in quality of life (PedsQL)
Body Weight Changes
Effect size for change in proportion with at least a 30 percent reduction in UPC
Effect size for change in urine protein:creatinine
Incidence of withdrawal due to adverse events
Proof of Concept Decision Criteria
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

10 Total Participants · 2 Treatment Groups

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

Intervention Group
Device
Experimental Group · 1 Intervention: trascutaneous 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 to 26 weeks

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,147 Previous Clinical Trials
4,074,638 Total Patients Enrolled
14 Trials studying Nephrotic Syndrome
6,418 Patients Enrolled for Nephrotic Syndrome
Northwell HealthLead Sponsor
425 Previous Clinical Trials
493,520 Total Patients Enrolled
3 Trials studying Nephrotic Syndrome
41 Patients Enrolled for Nephrotic Syndrome

Eligibility Criteria

Age 3 - 17 · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have steroid resistant nephrotic syndrome.
You have eGFR ≥30 ml/min/1.73 m2.
You have evidence of B cell repletion.
You are able to comply with the study protocol.