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

June 12, 2025 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02108
        • Recruiting
        • Novartis Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study will involve patients who has received Immunoglobulin A nephropathy diagnosis in US.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Immunoglobulin A nephropathy (IgAN)-Iptacopan
IgAN patients taking iptacopan and their caregivers
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.
IgAN-atrasentan
IgAN patients taking atrasentan and their caregivers
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.
IgAN-other treatment
IgAN patients taking other specific treatment and their caregivers
Other: Other treatment
Participants and their caregivers will report HRO data on symptom burden and treatment usage to understand symptom variability and HRQoL.
IgAN-no treatment
IgAN patients taking none treatment and their caregivers
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with IgAN specific symptoms
Time Frame: 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.
monthly up to month 6
Average self-reported severity of each of these top 10 symptoms
Time Frame: monthly up to month 6
To assess and gain a comprehensive understanding of the patient-reported burden of IgAN using HRO symptom tracking data.
monthly up to month 6
Variability in self-reported severity of each of these top 10 symptoms
Time Frame: monthly up to month 6
To assess and gain a comprehensive understanding of the patient-reported burden of IgAN using HRO symptom tracking data.
monthly up to month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average temporal frequency of treatment administration, for each IgAN-specific treatment
Time Frame: monthly up to month 6
To characterize IgAN treatment utilization patterns.
monthly up to month 6
Number of participants by reason for skipping treatment
Time Frame: monthly up to month 6
To identify participant reported reasons for skipping treatment.
monthly up to month 6
Differences in symptom occurrence for participants in each treatment group
Time Frame: monthly up to month 6
Symptom occurrence (number of participants who report it) between patients in each treatment group will be presented.
monthly up to month 6
Differences in symptom severity for participants in each treatment group
Time Frame: 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.
monthly up to month 6
Differences in symptom frequency for participants in each treatment group
Time Frame: 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.
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 symptom occurrence from pre- to post-iptacopan and/or atrasentan utilization, among patients receiving iptacopan and/or atrasentan.
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 symptom severity from pre- to post-iptacopan and/or atrasentan utilization, among patients receiving iptacopan and/or atrasentan.
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
Change in symptom frequency from pre- to post-iptacopan and/or atrasentan utilization, among patients receiving iptacopan and/or atrasentan.
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
To compare proportion of patients classified as high, moderate, or low flare burden between patients in each treatment group.
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
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.
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
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.
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

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.
monthly up to month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2025

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

February 26, 2025

First Submitted That Met QC Criteria

April 23, 2025

First Posted (Actual)

April 30, 2025

Study Record Updates

Last Update Posted (Actual)

June 17, 2025

Last Update Submitted That Met QC Criteria

June 12, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLNP023AUS02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Immunoglobulin A Nephropathy

Clinical Trials on Iptacopan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe