A Mobile App-Based, Prospective, Observational Study to Evaluate Disease Burden and Treatment Patterns in C3 Glomerulopathy (C3G) in the US
Novartis Pharmaceuticals
Summary
The study aims to longitudinally capture the full spectrum of symptoms, treatment utilization, and overall Health-related Quality of Life (HRQoL) experienced by C3 glomerulopathy (C3G) patients and their caregivers. By primarily utilizing home reported outcomes (HRO) data on symptom burden and treatment usage, supplemented with patient-reported outcome (PRO) measures (collected at baseline and monthly), the study seeks to establish a new real-world data (RWD) source to understand symptom variability and HRQoL as reported by C3G patients and caregivers, including those taking iptacopan
Description
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 gr…
Eligibility
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- No
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 dat…
Location
- Novartis Investigative SiteEast Hanover, New Jersey