C3 GlomerulopathyNCT07029542
Home Reported Outcomes in C3G Study
An observational study of C3 Glomerulopathy, run by Novartis Pharmaceuticals at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- C3 Glomerulopathy
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2025to 30 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
East Hanover, New Jersey, 07936
About this study
Official title: 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
Read the detailed description
The study will be prospective and observational, conducted over an initial period of six months per individual from the point of study enrollment, with the potential option for participants to extend data collection beyond this period through reconsenting procedures. Participants will utilize the Folia mobile app to enroll, consent, and complete all study activities. A hybrid referral-based recruitment method will be used to identify eligible participants such as through the Novartis APPRISE and MPGN data platforms, clinician referrals, specialty pharmacy inserts, and community and advocacy groups. Participants will be asked to track routine treatment, symptoms, changes in treatment plans, and HRQoL using the Folia Health mobile app. Monthly survey check-ins will be conducted to capture additional data inputs such as patient-reported outcomes (PROs) data, which may be tokenized and integrated into the relevant Novartis APPRISE or MPGN data platform during and after their data collection period. Additional real-world evidence (RWE) datasets such as electronic health record (EHR), claims, or wearable/device data may also be linked to this prospective dataset. Data from integration sources would serve as a complement to the primary study dataset; integration does not affect study objectives or endpoints, which are achieved through HRO tracking data. Participants will be consented for tokenization and linkage through language built into the informed consent form.
- Conditions
- C3 Glomerulopathy
- Keywords
- Home reported outcomes (HRO),, NIS,, FACIT-F,, EQ-5D,, Symptoms,, Treatments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| C3G | patients with confirmed diagnosis of C3 glomerulopathy (C3G) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 6 months
Secondary outcomes (7)
Average temporal frequency of treatment administration
Average temporal frequency of treatment administration, for each primary treatment
Measured: 6 months
Counts of patient-reported reasons for skipping treatment
Identification and counts of patient-reported reasons for skipping treatment
Measured: 6 moths
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).
Measured: 6 months
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
Measured: 6 months
Differences in number of participants by flare burden
Differences in number of participants in each treatment group who are classified as having a high vs moderate vs low flare burden
Measured: 6 months
Change over time in monthly check-in responses assessing HRQoL
Change over time in monthly check-in responses assessing HRQoL, for participants in each treatment group (and in the transplant vs no transplant groups, if possible)
Measured: 6 months
Differences in PRO scores
Differences in PRO scores, for participants in each treatment group (and in the transplant vs no transplant groups, if possible)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start7 Apr 2025
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for C3 GlomerulopathyStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029542
- Sponsor's protocol ID
- CLNP023B1US01
- Status last verified
- Jun 2025
- First submitted
- 11 Jun 2025
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile App-Based, Prospective, Observational Study to Evaluate Disease Burden and Treatment Patterns in C3 Glomerulopathy (C3G) in the US
- ClinicalTrials.gov ID
- NCT07029542
- Acronym / sponsor ID
- CLNP023B1US01
- Conditions
- C3 Glomerulopathy
- Keywords
- Home reported outcomes (HRO),, NIS,, FACIT-F,, EQ-5D,, Symptoms,, Treatments
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The study will be prospective and observational, conducted over an initial period of six months per individual from the point of study enrollment, with the potential option for participants to extend data collection beyond this period through reconsenting procedures. Participants will utilize the Folia mobile app to enroll, consent, and complete all study activities. A hybrid referral-based recruitment method will be used to identify eligible participants such as through the Novartis APPRISE and MPGN data platforms, clinician referrals, specialty pharmacy inserts, and community and advocacy groups. Participants will be asked to track routine treatment, symptoms, changes in treatment plans, and HRQoL using the Folia Health mobile app. Monthly survey check-ins will be conducted to capture additional data inputs such as patient-reported outcomes (PROs) data, which may be tokenized and integrated into the relevant Novartis APPRISE or MPGN data platform during and after their data collection period. Additional real-world evidence (RWE) datasets such as electronic health record (EHR), claims, or wearable/device data may also be linked to this prospective dataset. Data from integration sources would serve as a complement to the primary study dataset; integration does not affect study objectives or endpoints, which are achieved through HRO tracking data. Participants will be consented for tokenization and linkage through language built into the informed consent form.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| C3G | – | –patients with confirmed diagnosis of C3 glomerulopathy (C3G) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants reporting the top 10 symptoms most frequently self-reported
Time frame: 6 months
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
Participant average of self-reported severity of each of the top 10 symptoms
Time frame: 6 months
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
Within-participant variability in 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 over the course of the 6-month study
7 secondary outcomes
Average temporal frequency of treatment administration
Time frame: 6 months
Counts of patient-reported reasons for skipping treatment
Time frame: 6 moths
Proportion of participants who report symptom burden
Time frame: 6 months
Change in average symptom burden from pre-switch to post-switch, for participants who switched onto iptacopan during the study period
Time frame: 6 months
Differences in number of participants by flare burden
Time frame: 6 months
Change over time in monthly check-in responses assessing HRQoL
Time frame: 6 months
Differences in PRO scores
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of C3 Glomerulopathy, run by Novartis Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants reporting the top 10 symptoms most frequently self-reported (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.