Home-reported outcomes for people with C3 Glomerulopathy
A Mobile App-Based, Prospective, Observational Study to Evaluate Disease Burden and Treatment Patterns in C3 Glomerulopathy (C3G) in the US
This project will collect monthly home-reported symptoms, treatment use, and quality-of-life information from adults with C3 glomerulopathy and their caregivers to see how these change over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Novartis Industry-sponsored |
| Locations | 1 site (East Hanover, New Jersey) |
| Trial ID | NCT07029542 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are US-based adults with a clinical diagnosis of C3G, or adult caregivers of adult or pediatric C3G patients, who can read English, consent, and use a smartphone or tablet to run the Folia app.
Not a fit: Patients without reliable access to a smartphone or tablet, non-English speakers, those unable to provide informed consent, or those unwilling to permit tokenization/linkage of their data are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could give clinicians and researchers richer real-world insight into symptom patterns and quality of life in C3G, helping tailor care and design future trials.
How similar studies have performed: Longitudinal home-reported outcome collection has been useful in other kidney and rare-disease settings, but applying this approach specifically to C3G and linking it to Novartis APPRISE/MPGN platforms is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
East Hanover, New Jersey
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.