Immunoglobulin A Nephropathy
Conditions
Keywords
IgAN, HRQoL, Iptacopan, atrasentan, Immunoglobulin A nephropathy
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.
Interventions
OTHERNo 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).
OTHEROther treatment
Participants and their caregivers will report HRO data on symptom burden and treatment usage to understand symptom variability and HRQoL.
OTHERIptacopan
Participants and their caregivers will report HRO data on symptom burden and treatment usage to understand symptom variability and HRQoL including those taking iptacopan.
OTHERAtrasentan
Participants and their caregivers will report HRO data on symptom burden and treatment usage to understand symptom variability and HRQoL including those taking atrasentan.
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with IgAN specific symptoms | monthly up to month 6 | To assess and gain a comprehensive understanding of the patient-reported burden of Immunoglobulin A nephropathy (IgAN) using home-reported outcome (HRO) symptom tracking data. Patients will select from a list of suggested symptoms. The 10 symptoms most frequently reported will be presented and analyzed. |
| Average self-reported severity of each of these top 10 symptoms | monthly up to month 6 | To assess and gain a comprehensive understanding of the patient-reported burden of IgAN using HRO symptom tracking data. |
| Variability in self-reported severity of each of these top 10 symptoms | monthly up to month 6 | To assess and gain a comprehensive understanding of the patient-reported burden of IgAN using HRO symptom tracking data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average temporal frequency of treatment administration, for each IgAN-specific treatment | monthly up to month 6 | To characterize IgAN treatment utilization patterns. |
| Number of participants by reason for skipping treatment | monthly up to month 6 | To identify participant reported reasons for skipping treatment. |
| Differences in symptom occurrence for participants in each treatment group | monthly up to month 6 | Symptom occurrence (number of participants who report it) between patients in each treatment group will be presented. |
| Differences in symptom severity for participants in each treatment group | monthly up to month 6 | Symptom severity between patients in each treatment group will be presented. Severity is measured on a 1-5 severity scale with higher numbers indicating more severe symptoms. |
| Change in average symptom severity from pre-treatment to post-treatment utilization, for participants who initiated iptacopan or atrasentan during the study period | monthly up to month 6 | Change in symptom severity from pre- to post-iptacopan and/or atrasentan utilization, among patients receiving iptacopan and/or atrasentan. |
| Change in average symptom occurrence from pre-treatment to post-treatment utilization, for participants who initiated iptacopan or atrasentan during the study period | monthly up to month 6 | Change in symptom occurrence from pre- to post-iptacopan and/or atrasentan utilization, among patients receiving iptacopan and/or atrasentan. |
| Change over time in monthly check-in responses assessing health-related quality of life (HRQoL), for participants in each treatment group | monthly up to month 6 | To compare change in monthly HRQoL between patients in each treatment group. HRQoL will be assessed qualitatively through survey questions at monthly timepoints (no PRO scale), and participants will report on missed work or school, satisfaction with treatment plan, and frequency and characteristics of patient-defined difficult days. |
| Patient-reported outcome (PRO) scores for participants in each treatment group - FACIT-F | monthly up to month 6 | To compare change in monthly PRO scores between patients in each treatment group. The Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F) is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT ranges from 0 to 52, with 0 being the worst possible score and 52 the best. |
| Patient-reported outcome (PRO) scores for participants in each treatment group - EQ-5D-5L | monthly up to month 6 | To compare change in monthly PRO scores between patients in each treatment group. The EQ-5D-5L consists of 2 items - a descriptive system and a visual analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ VAS records the respondent's self-rated health on a 20-cm vertical, visual analogue scale numbered 0 to 100 with 100 meaning the best possible health. |
| Differences in symptom frequency for participants in each treatment group | monthly up to month 6 | To compare symptom frequency (instances of a symptom's occurrences divided by the total number of tracks) patients in each treatment group will be presented. |
| Change in average symptom frequency from pre-treatment to post-treatment utilization, for participants who initiated iptacopan or atrasentan during the study period | monthly up to month 6 | Change in symptom frequency from pre- to post-iptacopan and/or atrasentan utilization, among patients receiving iptacopan and/or atrasentan. |
| Number of participants in each treatment group who are classified as having a high vs moderate vs low flare burden | monthly up to month 6 | To compare proportion of patients classified as high, moderate, or low flare burden between patients in each treatment group. |
Countries
United States
Contacts
Primary ContactNovartis Pharmaceuticals
Backup ContactNovartis Pharmaceuticals
Outcome results
None listed