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

Novartis

Status: Enrolling

Conditions: Immunoglobulin A Nephropathy

Treatments: Other: Iptacopan; Other: Other treatment; Other: No intervention; Other: Atrasentan

Study type: Observational

Funder types: Industry

Identifiers

NCT06952426

CLNP023AUS02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 4 patient groups

Immunoglobulin A nephropathy (IgAN)-Iptacopan

Description:

IgAN patients taking iptacopan and their caregivers

Treatment:

Other: Iptacopan

IgAN-atrasentan

Description:

IgAN patients taking atrasentan and their caregivers

Treatment:

Other: Atrasentan

IgAN-other treatment

Description:

IgAN patients taking other specific treatment and their caregivers

Treatment:

Other: Other treatment

IgAN-no treatment

Description:

IgAN patients taking none treatment and their caregivers

Treatment:

Other: No intervention