Home Reported Outcomes in C3G Study

The study will be prospective and observational, conducted over an initial period of six months per individual from the point of study enrollment, with the potential option for participants to extend data collection beyond this period through reconsenting procedures. Participants will utilize the Folia mobile app to enroll, consent, and complete all study activities. A hybrid referral-based recruitment method will be used to identify eligible participants such as through the Novartis APPRISE and MPGN data platforms, clinician referrals, specialty pharmacy inserts, and community and advocacy groups. Participants will be asked to track routine treatment, symptoms, changes in treatment plans, and HRQoL using the Folia Health mobile app. Monthly survey check-ins will be conducted to capture additional data inputs such as patient-reported outcomes (PROs) data, which may be tokenized and integrated into the relevant Novartis APPRISE or MPGN data platform during and after their data collection period. Additional real-world evidence (RWE) datasets such as electronic health record (EHR), claims, or wearable/device data may also be linked to this prospective dataset. Data from integration sources would serve as a complement to the primary study dataset; integration does not affect study objectives or endpoints, which are achieved through HRO tracking data. Participants will be consented for tokenization and linkage through language built into the informed consent form.

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.