NCT06952426

A Mobile App-Based Study to Evaluate Disease Burden and Treatment Patterns in Immunoglobulin A Nephropathy (IgAN) in the US

A Mobile App-Based, Prospective, Observational Study to Evaluate Disease Burden and Treatment Patterns in Immunoglobulin A Nephropathy (IgAN) in the US

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study aims to longitudinally capture the full spectrum of symptoms, treatment utilization, and overall health-related quality of life (HRQoL) experienced by Immunoglobulin A nephropathy (IgAN) patients and their caregivers.

Detailed description

This will be a prospective, observational study. Data will be collected using the Folia Health platform. Participation in the study will occur through use of the Folia mobile platform, where study participants will be directed to a study-specific platform environment to review and sign the consent form and enroll. Each participant will complete an initial 6-month study data collection period which includes home reported outcomes (HRO) tracking along with study specific components including a baseline survey, monthly check-in prompts, and endline study evaluation survey. After the 6-month period, participants can continue to use Folia to track their HROs for their own personal use. With their consent, the data they enter after the initial 6-month period may be reviewed for ongoing data integrations with Novartis APPRISE data platform for up to 2 years.

Conditions

• Immunoglobulin A Nephropathy

Interventions

Type	Name	Description
OTHER	No intervention	Participants and their caregivers will report home reported outcomes (HRO) data on symptom burden to understand symptom variability and health-related quality of life (HRQoL).
OTHER	Other treatment	Participants and their caregivers will report HRO data on symptom burden and treatment usage to understand symptom variability and HRQoL.
OTHER	Iptacopan	Participants and their caregivers will report HRO data on symptom burden and treatment usage to understand symptom variability and HRQoL including those taking iptacopan.
OTHER	Atrasentan	Participants and their caregivers will report HRO data on symptom burden and treatment usage to understand symptom variability and HRQoL including those taking atrasentan.

Timeline

• Start date: 2025-03-04
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2025-04-30
• Last updated: 2025-06-17

Locations

1 site across 1 country: United States