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Vagus Nerve Stimulation for Nephrotic Syndrome (kidNEY-VNS Trial)
kidNEY-VNS Trial Summary
This trial will look at using noninvasive stimulation of the vagus nerve to treat nephrotic syndrome in children. It will assess safety, tolerability, and effectiveness of the therapy.
kidNEY-VNS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowkidNEY-VNS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.kidNEY-VNS Trial Design
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Who is running the clinical trial?
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- I have a known inflammatory condition.My B cells have returned to normal after rituximab treatment.I am between 3 and 17 years old.My immunosuppression and blood pressure medication have been stable for 3 months.My kidney condition improves with steroid treatment.Your kidney function is good, with an eGFR of at least 30 ml/min/1.73 m2.My kidney condition is not due to genetic, birth-related, or infectious causes.I have a long-lasting rash or skin issue on the left ear's inner part.You have a pacemaker, defibrillator, or other electronic device implanted in your body.The ratio of protein to creatinine in your urine is higher than 1.0.My kidney biopsy shows I have MCD or FSGS.My kidney condition did not improve after 4 weeks of standard steroid treatment.I have a genetic condition known to cause severe kidney disease.I have a history of heart disease.
- Group 1: Intervention Group
- Group 2: Sham Group
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are participants still able to join this experiment?
"As per the information hosted on clinicaltrials.gov, this research is currently seeking participants. The trial was initially posted to the website October 1st 2022 and has been updated most recently on October 13th of that same year."
Is the target demographic for this experiment restricted to those aged 50 or above?
"In order to take part in this research, participants must be aged between 3 and 17. 384 trials are available for minors, whilst 1003 studies welcome those over 65 years old."
What criteria must a person meet in order to be eligible for this research initiative?
"This trial seeks to recruit 10 children between the ages of 3 and 17 suffering from nephrotic syndrome. All prospective participants must meet various criteria, including but not limited to: Steroid Resistant Nephrotic Syndrome- as defined by lack of remission after a month on prednisolone/prednisone, eGFR ≥30 ml/min/1.73 m2 (as calculated using modified Schwartz formula), UPC greater than 1.0, B cell repletion in individuals who have been exposed to rituximab therapy, consent from parent or guardian for minors aged 7 and above and ability to comply"
How many individuals are being given treatment as part of this clinical research?
"Affirmative. Data on clinicaltrials.gov indicates that this medical experiment, first posted October 1st 2022, is actively seeking participants. There are 2 sites participating in the recruitment of 10 individuals for the trial."
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