Actively Recruiting
A Mobile App-Based, Prospective, Observational Study to Evaluate Disease Burden and Treatment Patterns in Immunoglobulin A Nephropathy (IgAN) in the US
Led by Novartis Pharmaceuticals · Updated on 2025-06-17
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a prospective, observational study to understand the full range of symptoms, treatment use, and overall quality of life experienced by patients with Immunoglobulin A nephropathy (IgAN) and their caregivers. The study aims to capture detailed data on these aspects over time to better reflect the patient experience and treatment patterns in the US. Participants will use the Folia Health mobile platform to enroll and provide data. The study includes IgAN patients taking different treatments such as iptacopan, atrasentan, other specific treatments, or no treatment, along with their caregivers. Each participant will complete a 6-month data collection period involving home-reported outcomes, baseline surveys, monthly check-ins, and an endline survey. After this period, participants may continue tracking symptoms for personal use, with optional data sharing for up to 2 years. During the study, participants report symptoms and treatment details monthly to assess symptom presence, severity, and variability. Researchers will also monitor treatment frequency, reasons for skipping treatment, and quality of life changes. Data collection includes patient-reported outcome scores and flare burden classification. The study involves no interventions and focuses on observation via the mobile app over the initial 6 months and potentially longer for ongoing data integration.
CONDITIONS
Brief Title
A Mobile App-Based Study to Evaluate Disease Burden and Treatment Patterns in Immunoglobulin A Nephropathy (IgAN) in the US
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of IgAN, regardless of symptom or treatment history
- Adult aged 18 or older; adult caregiver to an adult patient aged 18 or older; or adult caregiver to a pediatric patient under 18 years of age
- US-based with a proficient understanding of and ability to read the English language
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (remote via mobile app)
Duration - 6 months
Participants use the Folia mobile platform to report home outcomes and complete surveys to track symptom burden and treatment patterns.
Monthly check-in prompts via mobile app
Duration - Up to 2 years after initial 6 months
Participants may continue to use the mobile app to track outcomes for personal use, with data potentially reviewed for up to 2 years with consent.
Ongoing self-reporting via mobile app as desired
Trial Site Locations
Total: 1 location
1
Novartis Investigational site
Boston, Massachusetts, United States, 02108
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
N
Novartis Pharmaceuticals
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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