Home-reported outcomes for people with C3 Glomerulopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective observational project enrolls individuals with a clinical diagnosis of C3G (and their caregivers) to capture symptom burden, treatment utilization, and health-related quality of life over an initial six-month period. Participants enroll, consent, and complete monthly patient-reported outcome surveys through the Folia mobile app, reporting routine treatments, symptom changes, and instruments such as NIS, FACIT-F, and EQ-5D. Recruitment uses hybrid referral sources including Novartis APPRISE/MPGN platforms, clinician referrals, specialty pharmacies, and advocacy groups, and participants may extend data collection beyond six months by reconsenting. With participant permission, the dataset can be tokenized and linked to external real-world sources such as EHRs, claims, or wearable data to supplement the primary home-reported dataset.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Eligible participants will meet the following basic criteria:

* Clinical diagnosis of C3G, regardless of symptom, treatment, or transplant 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
* Able to provide informed consent
* Has access to technology (i.e. mobile phone, tablet) that facilitates their participation in the app-based study
* US-based with a proficient understanding of and ability to read the English language

The study team will aim to enroll and collect data on participants who are taking any form of treatment. Participants may be asked to recall the start date of taking their current therapy.

Diagnosis of C3G will be confirmed through self-reported screening procedures, patient-supplied documentation, and/or successful linkage of the patient's data with their record in a Novartis data platform. Confirmation of diagnosis for each participant will be reviewed by the Folia Health study team as part of standard validation procedures.

Exclusion Criteria:

Study participants who do not fit all inclusion criteria listed above are unable to participate in this study. Outside of the stated inclusion criteria, there is currently no other exclusion criteria in order to meet the exploratory nature of the primary endpoint. This includes treatment regimen; there is no exclusion criteria on the basis of treatment prescription or use.

Where it's running

• Novartis Investigative Site
  East Hanover, New Jersey, United States Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Long-term treatment with iptacopan for C3 glomerulopathy and IC-MPGN

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.