Home Reported Outcomes in C3G Study

Part of paid clinical trials in East Hanover, New Jersey.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07029542
Status
Recruiting

Conditions

  • C3 Glomerulopathy

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Study Details

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

Key Dates

Start date
Apr 7, 2025
Status verified
Jun 2025
Primary completion
Apr 30, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: 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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Novartis Investigative SiteEast HanoverNew Jersey07936-

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