Clinical trial NCT06952426: A Mobile App-Based Study to Evaluate Disease Burden and Treatment Patterns in Immunoglobulin A Nephropathy (IgAN) in the US
Official title: A Mobile App-Based, Prospective, Observational Study to Evaluate Disease Burden and Treatment Patterns in Immunoglobulin A Nephropathy (IgAN) in the US
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Immunoglobulin A Nephropathy
Keywords: IgAN
HRQoL
Iptacopan
atrasentan
Immunoglobulin A nephropathy
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2025-04-30
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will involve patients who has received Immunoglobulin A nephropathy diagnosis in US.

Brief 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: 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

Primary outcomes:
measure: Number of participants with IgAN specific symptoms
timeFrame: monthly up to month 6
measure: Average self-reported severity of each of these top 10 symptoms
timeFrame: monthly up to month 6
measure: Variability in self-reported severity of each of these top 10 symptoms
timeFrame: monthly up to month 6
Secondary outcomes:
measure: Average temporal frequency of treatment administration, for each IgAN-specific treatment
timeFrame: monthly up to month 6
measure: Number of participants by reason for skipping treatment
timeFrame: monthly up to month 6
measure: Differences in symptom occurrence for participants in each treatment group
timeFrame: monthly up to month 6
measure: Differences in symptom severity for participants in each treatment group
timeFrame: monthly up to month 6
measure: Differences in symptom frequency for participants in each treatment group
timeFrame: monthly up to month 6
measure: Change in average symptom occurrence from pre-treatment to post-treatment utilization, for participants who initiated iptacopan or atrasentan during the study period
timeFrame: monthly up to month 6
measure: Change in average symptom severity from pre-treatment to post-treatment utilization, for participants who initiated iptacopan or atrasentan during the study period
timeFrame: monthly up to month 6
measure: Change in average symptom frequency from pre-treatment to post-treatment utilization, for participants who initiated iptacopan or atrasentan during the study period
timeFrame: monthly up to month 6
measure: Number of participants in each treatment group who are classified as having a high vs moderate vs low flare burden
timeFrame: monthly up to month 6
measure: Change over time in monthly check-in responses assessing health-related quality of life (HRQoL), for participants in each treatment group
timeFrame: monthly up to month 6
measure: Patient-reported outcome (PRO) scores for participants in each treatment group - FACIT-F
timeFrame: monthly up to month 6
measure: Patient-reported outcome (PRO) scores for participants in each treatment group - EQ-5D-5L
timeFrame: monthly up to month 6
Other outcomes:
Locations:
city: Boston
country: United States
facility: Novartis Investigational site
state: Massachusetts
Study officials:
References: