Recruiting

Observational Study

Sponsor:

Novartis Pharmaceuticals

Code:

NCT06952426

Conditions

Immunoglobulin A Nephropathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

No intervention

Other treatment

Iptacopan

Atrasentan

Study Details

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

Study ID

NCT06952426

Start date

Mar 4, 2025

Status verified date

Jun, 2025

Completion date

Jun 30, 2025

Anticipated

Primary completion date

Jun 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Immunoglobulin A nephropathy (IgAN)-Iptacopan

IgAN patients taking iptacopan and their caregivers

IgAN-atrasentan

IgAN patients taking atrasentan and their caregivers

IgAN-other treatment

IgAN patients taking other specific treatment and their caregivers

IgAN-no treatment

IgAN patients taking none treatment and their caregivers

Interventions

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.

Primary outcome measure

  • Number of participants with IgAN specific symptoms [ Time Frame: monthly up to month 6 ]
  • Average self-reported severity of each of these top 10 symptoms [ Time Frame: monthly up to month 6 ]
  • Variability in self-reported severity of each of these top 10 symptoms [ Time Frame: monthly up to month 6 ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

+41613241111novartis.email@novartis.com

Locations

Novartis Investigational site

Recruiting

Boston, Massachusetts, United States, 02108

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Jun 17, 2025

Last verified

Jun, 2025

Keywords

  • IgAN
  • HRQoL
  • Iptacopan
  • atrasentan
  • Immunoglobulin A nephropathy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2025-06-17.