Home Reported Outcomes in C3G Study

NCT07029542 | Recruiting

• 1 other identifier: CLNP023B1US01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Number of participants reporting the top 10 symptoms most frequently self-reported

  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

  6 months

• Participant average of self-reported severity of each of the top 10 symptoms

  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

  6 months

• Within-participant variability in self-reported severity of each of the top 10 symptoms

  Within-participant variability in self-reported severity of each of the top 10 symptoms over the course of the 6-month study

  6 months

Secondary Outcomes (7)

• Average temporal frequency of treatment administration

  6 months

• Counts of patient-reported reasons for skipping treatment

  6 moths

• Proportion of participants who report symptom burden

  6 months

• Change in average symptom burden from pre-switch to post-switch, for participants who switched onto iptacopan during the study period

  6 months

• Differences in number of participants by flare burden

  6 months

Study Arms (1)

C3G

patients with confirmed diagnosis of C3 glomerulopathy (C3G)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A sample of 100 adults, caregivers of adults, or caregivers of children diagnosed with C3G across an initial 8-month enrollment period. The study team will aim to enroll approximately 50 participants who report taking iptacopan and 50 participants who are not taking a primary therapy of interest.

You may qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

East Hanover, New Jersey, 07936, United States

RECRUITING

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

1-888-669-6682; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 19, 2025
• Study Start: April 7, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)