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
Eligibility
Sex
ALL
Min age
18 Years
Max age
100 Years
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 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.
Primary outcome measure(s)
Number of participants reporting the top 10 symptoms most frequently self-reported — 6 months Identification of the top 10 symptoms most frequently self-reported by participants, as well as the total number of participants reporting each of those symptoms
Participant average of self-reported severity of each of the top 10 symptoms — 6 months Across-participant average (and standard deviation) of self-reported severity of each of the top 10 symptoms over the course of the 6-month study
Within-participant variability in self-reported severity of each of the top 10 symptoms — 6 months Within-participant variability in self-reported severity of each of the top 10 symptoms over the course of the 6-month study
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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