Last Update: Apr 30, 2025
A Mobile App-Based, Prospective, Observational Study to Evaluate Disease Burden and Treatment Patterns in Immunoglobulin A Nephropathy (IgAN) in the US
ClinicalTrials.gov Identifier:
Novartis Reference Number:CLNP023AUS02
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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. 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.

Immunoglobulin A Nephropathy
Recruiting
300
Mar 04, 2025
Jun 30, 2025
All
18 Years - (Adult, Older Adult)

Interventions

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.
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

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.

Eligibility Criteria

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

Novartis Investigational site

Recruiting

Boston,Massachusetts,02108,United States

Worldwide Contacts

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Novartis Pharmaceuticals