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

NCT06952426 · tracked via the Priya Life Science USA tracker

Sponsor

Novartis Pharmaceuticals

Phase

Observational

Started

2025-03-04

Last updated

2025-06-17

Condition(s) studied

Immunoglobulin A Nephropathy

Investigational drug(s) / intervention(s)

No interventionOther treatmentIptacopanAtrasentan

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

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.

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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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 outcome measure(s)

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.

Trial sites (1)

Facility	City	Region	Status
Novartis Investigational site	Boston	Massachusetts	Recruiting

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Other trials for the same condition

Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN) Active, not recruiting

Study of Ravulizumab in Pediatric Participants With Primary IgAN Recruiting

A Phase 3 Open-Label Study of Long-term Treatment With Povetacicept in Adults With Immunoglobulin A Nephropathy Enrolling by invitation

Atrasentan in Patients With IgA Nephropathy Active, not recruiting

Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06952426 on ClinicalTrials.gov ↗ ← All trials in the USA