What side effects are associated with this type of intervention?

Common treatments for Nephrotic Syndrome include prolonged courses of steroids and other immunosuppressant medications. These treatments often have significant side effects such as increased risk of infections, weight gain, hypertension, diabetes, osteoporosis, and growth retardation in children. Immunomodulatory therapies like taVNS, which are being studied for their potential benefits, aim to reduce these adverse effects by modulating the inflammatory reflex and spleen. However, specific side effects of taVNS are still under investigation, with current studies focusing on its feasibility and tolerability.

What prior FDA approvals exist?

The FDA has approved several treatments for Nephrotic Syndrome, primarily focusing on immunosuppressive therapies. These include corticosteroids like prednisone, which are commonly used as first-line treatments. Other immunosuppressants such as cyclophosphamide, mycophenolate mofetil, and calcineurin inhibitors like tacrolimus and cyclosporine have also been approved. These treatments aim to reduce inflammation and modulate the immune response, similar to the immunomodulatory effects being studied with transcutaneous auricular vagus nerve stimulation (taVNS). While taVNS itself is a novel approach and not yet FDA-approved for Nephrotic Syndrome, it represents a potential future direction in leveraging the body's inflammatory reflex and spleen for therapeutic benefit.

What other types of research exist?

Promising novel alternatives to taVNS for nephrotic syndrome patients include intravenous immunoglobulin (IVIG) therapy, plasma exchange, and combined immunomodulatory therapy with mycophenolate mofetil and prednisone. These therapies have shown efficacy in other immune-mediated conditions and could be considered for nephrotic syndrome treatment.

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Device

taVNS for Nephrotic Syndrome in Children (kidNEY-VNS Trial)

N/A

Recruiting

Research Sponsored by Northwell Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 3-17 years

Minimal change disease (MCD) or focal segmental glomerulosclerosis (FSGS) diagnosis (clinical diagnosis or per biopsy)

Must not have

Any known inflammatory condition (e.g. systemic lupus erythematosis)

History of cardiac disease (arrhythmias, structural/functional abnormalities)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through 26 weeks

Summary

This trial tests a new treatment for children with frequently relapsing nephrotic syndrome using a device that sends gentle electrical pulses to the ear. The goal is to see if this method can safely help manage their condition by reducing inflammation through nerve stimulation.

Who is the study for?

This trial is for children aged 3-17 with frequently relapsing nephrotic syndrome, specifically those diagnosed with Minimal Change Disease or Focal Segmental Glomerulosclerosis. They must be in remission and have responded to steroids before. Kids can't join if they've taken steroids recently, are on other immunosuppressants, have electronic implants, are pregnant, or have certain heart diseases or inflammatory conditions.

What is being tested?

The study tests transcutaneous auricular vagus nerve stimulation (taVNS), a non-invasive treatment that might regulate the immune system without drugs' side effects. Children will be randomly assigned to either real taVNS therapy or a sham device to compare effectiveness and impact on inflammation markers.

What are the potential side effects?

While specific side effects of taVNS aren't detailed here, similar non-invasive nerve stimulation treatments may cause mild skin irritation at the site of application, headache, dizziness or changes in heart rate.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 3 and 17 years old.

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I have been diagnosed with MCD or FSGS.

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My kidney function, measured by eGFR, is at least 30.

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My kidney condition is currently in remission.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an inflammatory condition like lupus.

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I have a history of heart disease.

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My kidney condition gets worse quickly after stopping or while on steroids.

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My kidney condition is caused by another disease.

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I have steroid-resistant nephrotic syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through 26 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through 26 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 26 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Success of Pilot Trial

Secondary study objectives

Adverse events

Anti-nephrin antibodies

Cytokine

+11 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Intervention GroupExperimental Treatment1 Intervention

The intensity setting for pulse amplitude will be adjusted to the participant's tolerance (if a sensation is felt) to a maximum level of 3 on the dial indicator. The remaining settings will be stored in the device and will not need to be set for each treatment. Participants and guardians will be instructed to adjust intensity to highest level of tolerance each time the device is used and level will be logged.

Group II: Sham GroupPlacebo Group1 Intervention

The sham device will be disabled internally so that electrical stimulation is not delivered, but the device will appear to function. Externally, the sham device will look identical to the taVNS device. The participant will be told to increase the intensity until tolerated if a sensation is felt, but will be asked to stop at a maximum level of 3. This inactive sham method was chosen because previous studies have shown that stimulation with placement of the ear clip on other parts of the ear such as the earlobe, although not innervated by the vagus nerve, results in some vagus nerve activity. Inactive sham methodology has been used in previous studies.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcutaneous auricular vagus nerve stimulation

2023

N/A

~40

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Nephrotic Syndrome often involve immunosuppressive therapies such as corticosteroids and cyclophosphamide, which reduce inflammation and immune system activity to prevent kidney damage. These treatments are crucial because Nephrotic Syndrome is typically caused by an immune-mediated attack on the kidneys. Emerging therapies like Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) aim to modulate the immune response through the inflammatory reflex and spleen, potentially offering a novel, non-invasive approach to managing the disease. This matters for patients as it could reduce reliance on medications with significant side effects, improving quality of life and treatment outcomes.

Increased 5-lipoxygenase activating protein in immune-mediated experimental nephritis.