A Mobile App-Based, Prospective, Observational Study to Evaluate Disease Burden and Treatment Patterns in C3 Glomerulopathy (C3G) in the US

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

CT.gov Identifier
NCT07029542
EudraCT Identifier
N/A
CTIS:
N/A
Sponsor
Novartis
Collaborator
N/A
Study Contact Information
+41 61 324 0000
Recruiting
Contact Us

Study Details

Diseases
Glomerulonephritis and atypical hemolytic uremic syndrome (aHUS)
Atypical Hemolytic Uremic Syndrome; C3 Glomerulopathy; Complement Factor H Deficiency
Study Drug
Iptacopan
Genes
CFI
CFH
Study Dates
Apr 2025 - Apr 2026
Sex
Female & Male
Age
18 - 100 Years
Inclusion and 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.

Protocol 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

Study Locations

To view all trial locations, click here

Contact Us About More Information for the Clinical Trial Concierge Service

Natera’s Clinical Trial Concierge Program is comprised of a dedicated team that helps connect providers and patients with appropriate clinical trials. To learn more about a trial offered through this service, please complete the form below.  

Fields marked with asterisk (*) are mandatory.

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.