Home Reported Outcomes in C3G Study
ConditionC3 Glomerulopathy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorNovartis Pharmaceuticals
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial 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.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 1 trial groupGroup A: C3G
Trial outcomes
Primary outcomes
1
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
Time frame
6 months2
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
Time frame
6 months3
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
Time frame
6 monthsSecondary outcomes
1
Average temporal frequency of treatment administration
Average temporal frequency of treatment administration, for each primary treatment
Time frame
6 months2
Counts of patient-reported reasons for skipping treatment
Identification and counts of patient-reported reasons for skipping treatment
Time frame
6 moths3
Proportion of participants who report symptom burden
Differences in symptom burden for participants in each treatment group, including symptom occurrence (proportion of participants who report it), severity (when reported), and frequency (when reported).
Time frame
6 months4
Change in average symptom burden from pre-switch to post-switch, for participants who switched onto iptacopan during the study period
Change in average symptom burden (including occurrence, severity, and frequency) from pre-switch to post-switch, for participants who switched onto iptacopan during the study period, if there are enough participants who switch
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov