What is this study trying to find out about Immunoglobulin A nephropathy (IgAN)?

This study aims to collect detailed information on symptoms, treatment use, and quality of life for people with IgAN and their caregivers. Researchers want to understand how the disease and treatments affect daily life over time. The study is sponsored by Novartis Pharmaceuticals and uses a mobile app to gather data.

Who may be eligible for this Immunoglobulin A nephropathy (IgAN) clinical trial?

Adults aged 18 or older with IgAN, or adult caregivers of adult or pediatric IgAN patients, may be eligible. Participants must live in the US and be able to read English well. There are no specific exclusion criteria. Please review eligibility criteria for more details.

Is there any cost to participate in this Immunoglobulin A nephropathy (IgAN) clinical trial?

Study-related care, including the use of the mobile app and all trial activities, is provided at no cost. Personal expenses such as travel or internet access may vary and are not guaranteed to be covered. Participants can expect to use their own devices to report data.

Actively Recruiting

Age: 18Years +

All Genders

ID06952426

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

Research Sites

N/A

Total Duration

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

Age: 18Years +

All Genders

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...

Research Team

Novartis Pharmaceuticals

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