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NCT06952426Recruiting

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

Novartis Pharmaceuticals

Start Date

3/4/2025

Completion Date

6/30/2025

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 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 Exclusion Criteria: None

Interventions

OTHER

No intervention

OTHER

Other treatment

OTHER

Iptacopan

OTHER

Atrasentan

Interested in This Trial?

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Conditions

Immunoglobulin A Nephropathy

Locations

Novartis Investigational site

Boston, Massachusetts 02108

United States