A Mobile App-Based Study to Evaluate Disease Burden and Treatment Patterns in Immunoglobulin A Nephropathy (IgAN) in the US
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention, Other treatment, Iptacopan, Atrasentan.
- Who it may be relevant to
- Registry conditions: Immunoglobulin A Nephropathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Mobile App-Based, Prospective, Observational Study to Evaluate Disease Burden and Treatment Patterns in Immunoglobulin A Nephropathy (IgAN) in the US
Overview
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.
Interventions
- 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. - 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 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.
Primary outcome measures
- Number of participants with IgAN specific symptoms [Time frame: monthly up to month 6]
- Average self-reported severity of each of these top 10 symptoms [Time frame: monthly up to month 6]
- Variability in self-reported severity of each of these top 10 symptoms [Time frame: monthly up to month 6]
Secondary outcome measures (12)
- Average temporal frequency of treatment administration, for each IgAN-specific treatment [Time frame: monthly up to month 6]
- Number of participants by reason for skipping treatment [Time frame: monthly up to month 6]
- Differences in symptom occurrence for participants in each treatment group [Time frame: monthly up to month 6]
- Differences in symptom severity for participants in each treatment group [Time frame: monthly up to month 6]
- Differences in symptom frequency for participants in each treatment group [Time frame: monthly up to month 6]
- Change in average symptom occurrence from pre-treatment to post-treatment utilization, for participants who initiated iptacopan or atrasentan during the study period [Time frame: monthly up to month 6]
- Change in average symptom severity from pre-treatment to post-treatment utilization, for participants who initiated iptacopan or atrasentan during the study period [Time frame: monthly up to month 6]
- Change in average symptom frequency from pre-treatment to post-treatment utilization, for participants who initiated iptacopan or atrasentan during the study period [Time frame: monthly up to month 6]
- Number of participants in each treatment group who are classified as having a high vs moderate vs low flare burden [Time frame: monthly up to month 6]
- Change over time in monthly check-in responses assessing health-related quality of life (HRQoL), for participants in each treatment group [Time frame: monthly up to month 6]
- Patient-reported outcome (PRO) scores for participants in each treatment group - FACIT-F [Time frame: monthly up to month 6]
- Patient-reported outcome (PRO) scores for participants in each treatment group - EQ-5D-5L [Time frame: monthly up to month 6]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Novartis Investigational site — Boston
Identifiers
NCT: NCT06952426 · CLNP023AUS02