Recruiting

Iptacopan

Sponsor:

Novartis Pharmaceuticals

Code:

NCT07029542

Conditions

C3 Glomerulopathy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief 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

Conditions

C3 Glomerulopathy

Study ID

NCT07029542

Start date

Apr 7, 2025

Status verified date

Jun, 2025

Completion date

Apr 30, 2026

Anticipated

Primary completion date

Apr 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

C3G

patients with confirmed diagnosis of C3 glomerulopathy (C3G)

Primary outcome measure

  • Number of participants reporting the top 10 symptoms most frequently self-reported [ Time Frame: 6 months ]
  • Participant average of self-reported severity of each of the top 10 symptoms [ Time Frame: 6 months ]
  • Within-participant variability in self-reported severity of each of the top 10 symptoms [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

Novartis Investigative Site

Recruiting

East Hanover, New Jersey, United States, 07936

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Jun 19, 2025

Last verified

Jun, 2025

Keywords

  • Home reported outcomes (HRO),
  • NIS,
  • FACIT-F,
  • EQ-5D,
  • Symptoms,
  • Treatments

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2025-06-19.