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

NCT ID: NCT06952426

Last Updated: 2025-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-04

Study Completion Date

2025-06-30

Brief Summary

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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

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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.

Conditions

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Immunoglobulin A Nephropathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Immunoglobulin A nephropathy (IgAN)-Iptacopan

IgAN patients taking iptacopan and their caregivers

Iptacopan

Intervention Type OTHER

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

Atrasentan

Intervention Type OTHER

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 treatment

Intervention Type OTHER

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

No intervention

Intervention Type OTHER

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).

Interventions

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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).

Intervention Type OTHER

Other treatment

Participants and their caregivers will report HRO data on symptom burden and treatment usage to understand symptom variability and HRQoL.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Novartis Investigational site

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Novartis Pharmaceuticals

Role: CONTACT

+41613241111

Novartis Pharmaceuticals

Role: CONTACT

Other Identifiers

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CLNP023AUS02

Identifier Type: -

Identifier Source: org_study_id

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