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

NCT06952426 | Recruiting

• 1 other identifier: CLNP023AUS02
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Immunoglobulin A Nephropathy

Keywords

IgAN; HRQoL; Iptacopan; atrasentan; Immunoglobulin A nephropathy

Outcome Measures

Primary Outcomes (3)

• Number of participants with IgAN specific symptoms

  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

  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

  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 Outcomes (12)

• Average temporal frequency of treatment administration, for each IgAN-specific treatment

  monthly up to month 6

• Number of participants by reason for skipping treatment

  monthly up to month 6

• Differences in symptom occurrence for participants in each treatment group

  monthly up to month 6

• Differences in symptom severity for participants in each treatment group

  monthly up to month 6

• Differences in symptom frequency for participants in each treatment group

  monthly up to month 6

Study Arms (4)

Immunoglobulin A nephropathy (IgAN)-Iptacopan

IgAN patients taking iptacopan and their caregivers

Other: Iptacopan

IgAN-atrasentan

IgAN patients taking atrasentan and their caregivers

Other: Atrasentan

IgAN-other treatment

IgAN patients taking other specific treatment and their caregivers

Other: Other treatment

IgAN-no treatment

IgAN patients taking none treatment and their caregivers

Other: No intervention

Interventions

No intervention 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).

IgAN-no treatment

Other treatment OTHER

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

IgAN-other treatment

Iptacopan 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.

Immunoglobulin A nephropathy (IgAN)-Iptacopan

Atrasentan 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-atrasentan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigational site

Boston, Massachusetts, 02108, United States

RECRUITING

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

iptacopan; Atrasentan

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Benzodioxoles; Dioxoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrrolidines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: April 30, 2025
• Study Start: March 4, 2025
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)