What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Idiopathic Nephrotic Syndrome (INS), including corticosteroids like prednisone, which are often the first line of treatment. Immunosuppressive agents such as cyclophosphamide and mycophenolate mofetil are also used, particularly in patients who do not respond to steroids. These treatments aim to reduce proteinuria and manage symptoms. The UrApp study focuses on improving self-management of INS, which complements these pharmacological treatments by helping patients and caregivers adhere to medication regimens and monitor disease activity effectively.

What other types of research exist?

Promising alternatives to UrApp for the self-management of idiopathic nephrotic syndrome in 2024 may include: 1) AI-driven health monitoring apps that provide personalized feedback and predictive analytics for disease management. 2) Telehealth platforms offering real-time consultations and remote monitoring with nephrologists. 3) Wearable devices integrated with mobile apps to track vital signs and medication adherence. 4) Gamified health apps that engage patients, especially children, in managing their condition through interactive and educational activities.

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Mobile App for Nephrotic Syndrome Management

Q: What side effects are associated with this type of intervention?

The most common treatments for idiopathic nephrotic syndrome include glucocorticoids and immunosuppressive agents. Glucocorticoids, such as prednisone, can cause side effects like weight gain, hypertension, hyperglycemia, increased risk of infections, and osteoporosis. Immunosuppressive agents, such as cyclophosphamide and mycophenolate mofetil, may lead to bone marrow suppression, increased susceptibility to infections, gastrointestinal disturbances, and potential long-term risks of malignancy. These side effects highlight the importance of careful monitoring and adherence to prescribed regimens, which tools like UrApp aim to support.

N/A

Waitlist Available

Led By Chia-shi Wang, MD, MS

Research Sponsored by Emory University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Caregivers of pediatric patients with end-stage kidney disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 6, month 12

Awards & highlights

No Placebo-Only Group

Summary

This trial tests UrApp, a mobile app that helps families manage nephrotic syndrome in children by tracking urine tests and medication. It targets caregivers of children who struggle with disease management. The app uses the phone's camera to read urine tests, reminds caregivers to check urine, tracks results, and alerts doctors if needed.

Who is the study for?

This trial is for caregivers of children aged 1-17 newly diagnosed with steroid-sensitive nephrotic syndrome, a chronic kidney disease. Participants must have internet access, be proficient in English, and the child should respond to steroids within 4 weeks. It's not for those caring for kids who've had a kidney transplant or have secondary causes like lupus.

What is being tested?

The study tests if UrApp, a mobile app designed to help manage nephrotic syndrome in children, improves self-management and health outcomes compared to standard care alone. Caregivers will either use UrApp or follow usual care without the app over one year.

What are the potential side effects?

Since this trial involves using an application (UrApp) rather than medication, traditional side effects are not expected. However, there may be indirect consequences such as increased anxiety or reliance on the technology that could affect caregiver or patient well-being.

Eligibility Criteria

Exclusion Criteria

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

Select...

I am a caregiver for a child with severe kidney disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 6, month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 6, month 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6, month 12 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Medication Adherence

Change in Urine Monitoring Adherence

Secondary study objectives

Change in Delayed Relapse Detection

Change in Hospitalizations

Change in Patient-Reported Outcomes Measurement Information System - Pediatric Quality of Life Inventory (PedsQL) Score

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: UrAppExperimental Treatment2 Interventions

Participants randomized to this study arm will use the UrApp mobile application for one year, in addition to receiving the standard of care.

Group II: Standard of CareActive Control1 Intervention

Participants randomized to this study arm will use receive the standard of care for one year.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Standard of Care

2017

Completed Phase 4

~4420

0 / 1Eligibility 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

The most common treatments for Idiopathic Nephrotic Syndrome (INS) include corticosteroids, immunosuppressive agents, and supportive care measures. Corticosteroids like prednisone reduce inflammation and suppress the immune system, helping to decrease proteinuria and induce remission. Immunosuppressive agents such as cyclophosphamide and mycophenolate mofetil are used in steroid-resistant cases to further suppress the immune response and reduce kidney damage. Supportive care measures, including ACE inhibitors or ARBs, help manage symptoms like proteinuria and hypertension. These treatments are crucial for managing INS as they aim to reduce protein loss, prevent relapses, and maintain kidney function. The UrApp trial focuses on improving self-management, which is essential for adherence to these treatments and ultimately better health outcomes.