 Last Update: Jun 17, 2025 

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

ClinicalTrials.gov Identifier: [NCT06952426](https://clinicaltrials.gov/ct2/show/NCT06952426)

 

Novartis Reference Number:CLNP023AUS02

 

 [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") 

 All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

 

##  Study Description 

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. 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.



 

 Condition Immunoglobulin A Nephropathy 

 

 Overall Status Recruiting 

 

 Number of Participants300

 

 

 Start Date Mar 04, 2025 

 

 Completion Date Jun 30, 2025 

 

 Gender All 

 

 Age(s) 18 Years - (Adult, Older Adult) 

 

 

 

##  Interventions 

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.

 



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.

 



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).

 



Other

### Other treatment



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

 



 

 

 

##  Eligibility Criteria 

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



 

 United States 

####  Novartis Investigational site 

Recruiting

 Boston,Massachusetts,02108,United States

 

 

 

 

 

 

 

 

 

##  Worldwide Contacts 

If the location of your choosing does not feature any contact detail, please reach out using the information below.

#### Novartis Pharmaceuticals

Phone: [ +41613241111](tel:+41613241111) 

Email: <novartis.email@novartis.com>