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New treatment option for Nephrotic Syndrome in Children
Official title taVNS for FRNS in Children
ClinicalTrials.gov ID: NCT05588063
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 17
You may be able to join if
- FRNS
- Age 3-17 years
- Glomerular filtration rate (eGFR) ≥30 ml/min/1.73 m2
- Minimal change disease (MCD) or focal segmental glomerulosclerosis (FSGS) diagnosis (clinical diagnosis or per biopsy)
- Steroid sensitive nephrotic syndrome (prior history of remission within 4 weeks of steroid therapy)
You likely can't join if
- Secondary forms of nephrotic syndrome
- SRNS
- Steroid dependent nephrotic syndrome (relapse within 14 days of stopping steroids or relapse while on steroids)
- Exposure to steroids within 14 days of enrollment
- Receiving any standing immunosuppression (previous exposure \> 2 months allowed and/or B cell repletion)
- Any known inflammatory condition (e.g. systemic lupus erythematosis)
See the full eligibility criteria
- FRNS
- Age 3-17 years
- Glomerular filtration rate (eGFR) ≥30 ml/min/1.73 m2
- Minimal change disease (MCD) or focal segmental glomerulosclerosis (FSGS) diagnosis (clinical diagnosis or per biopsy)
- Steroid sensitive nephrotic syndrome (prior history of remission within 4 weeks of steroid therapy)
- In remission at time of enrollment (remission defined as UPC \<0.2 or negative dipstick for 3 consecutive days)
- Informed consent from the parent or guardian and assent from a minor of ≥ 7. years
- Secondary forms of nephrotic syndrome
- SRNS
- Steroid dependent nephrotic syndrome (relapse within 14 days of stopping steroids or relapse while on steroids)
- Exposure to steroids within 14 days of enrollment
- Receiving any standing immunosuppression (previous exposure \> 2 months allowed and/or B cell repletion)
- Any known inflammatory condition (e.g. systemic lupus erythematosis)
- History of cardiac disease (arrhythmias, structural/functional abnormalities)
- Implantable electronic devices
- Pregnancy
- Participants/guardians or participants who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures
The study team makes the final eligibility decision.
Where it's taking place
- New Hyde Park, New York, United States
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Hyde Park, New York, United States; Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.