CompletedNot Applicable

UrApp for Childhood Nephrotic Syndrome Management (Incident Cohort)

United States58 participantsStarted 2019-09-17

Plain-language summary

Idiopathic nephrotic syndrome is one of the most common chronic kidney diseases in children. Patients suffer from frequent disease relapses and complications. Self-management is difficult for families and nonadherence is common, with adverse effects on the children's health. UrApp is a mobile application designed to assist families with nephrotic syndrome management. This study will examine whether providing the children's caregivers (or adolescent patients) with UrApp improves self-management and disease outcomes. This study will include 60 caregivers of children with newly diagnosed nephrotic syndrome. Participants will be randomized 1:1 to UrApp or standard of care and followed for 1 year.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Caregivers of patients ages 1-17 with steroid sensitive nephrotic syndrome (clinical diagnosis with edema, nephrotic range proteinuria \[urine protein to creatinine ratio \>2 mg/mg, or ≥ 300 mg/dL or ≥ 3+ protein on urine dipstick\], and hypoalbuminemia ≤ 2.5 g/dL; resolution of proteinuria \[negative/trace protein on urine dipstick\] within 4 weeks of corticosteroid treatment) * Caregivers of pediatric patients with steroid sensitive nephrotic syndrome diagnosed within 42 days at the time of enrollment * Access to internet/wireless fidelity (Wi-Fi) in the home * Caregiver proficiency with the English language Exclusion Criteria: * Caregivers of pediatric patients with end-stage kidney disease * Caregivers of pediatric patients with renal transplantation * Caregivers of pediatric patients with clinical or histologic evidence of secondary nephrotic syndrome (e.g., systemic lupus erythematosus)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants Reporting Medication Adherence

Timeframe: Baseline, Month 6, Month 12

Number of Participants Reporting Adherence With Urine Monitoring

Timeframe: Baseline, Month 6, Month 12

Trial details

NCT IDNCT04075656

SponsorEmory University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-25

Results submitted2025-09-11

View on ClinicalTrials.gov More Idiopathic Nephrotic Syndrome trials