C3 GlomerulopathyNCT07156149
Fabhalta Capsules Specified Drug-use Survey
An observational study of C3 Glomerulopathy, run by Novartis Pharmaceuticals at 29 sites in Japan.
Trial summary
The objective of this study is to evaluate the safety and effectiveness of Fabhalta in patients with C3 glomerulopathy in clinical practice. Read more about this study
- Who is it for?
- Ages 0 to 100 years
- Conditions the study is for
- C3 Glomerulopathy
- How many people
- 33 participants
- Where
- 29 sitesJapan
- Study dates
- 17 Sep 2025to 30 Jun 2028
- 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 0 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who received Fabhalta.
Who may be able to join
- All patients who have used Fabhalta for C3 glomerulopathy (including patients with recurrent C3 glomerulopathy post renal transplant).
Who cannot join
- Use of iptacopan for an indication not yet approved under the Clinical Trials Act or GCP (e.g., patient-requested medical treatment, investigator-initiated clinical trial)
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
Japan29 sites
Novartis Investigative Site
Bunkyo-ku, Tokyo, 1138519
Novartis Investigative Site
Chiba, Chiba, 2608677
Novartis Investigative Site
Fuchū, Tokyo, 1838561
Novartis Investigative Site
Fukuoka, Fukuoka, 810-8563
Novartis Investigative Site
Hirosaki, Aomori, 0368563
Novartis Investigative Site
Hiroshima, 7348530
Novartis Investigative Site
Ishikawa, 9208641
Novartis Investigative Site
Kitakyushu, Fukuoka, 8028555
Novartis Investigative Site
Komatsu, Ishikawa-ken, 923-0961
Novartis Investigative Site
Kusatsu, Shiga, 525-8585
Novartis Investigative Site
Nagasaki, Nagasaki, 852-8501
Novartis Investigative Site
Nagoya, Aichi-ken, 466-8650
Novartis Investigative Site
Nakano City, Tokyo, 164-8607
Novartis Investigative Site
Nara, 630-8581
Novartis Investigative Site
Ohtsu, Shiga, 5202192
Novartis Investigative Site
Sapporo, Hokkaido, 0040041
Novartis Investigative Site
Sapporo, Hokkaido, 0608604
Novartis Investigative Site
Shimotsuga Gun, Tochigi, 3210293
Novartis Investigative Site
Shinjuku Ku, Tokyo, 1628666
Novartis Investigative Site
Shizuoka, Shizuoka, 420-8527
Novartis Investigative Site
Suita, Osaka, 565-0871
Novartis Investigative Site
Takatsuki, Osaka, 5698686
Novartis Investigative Site
Tokushima, Tokushima, 7708503
Novartis Investigative Site
Tosa-gun, Kyoto, 629-2261
Novartis Investigative Site
Toyoake, Aichi-ken, 4701192
Novartis Investigative Site
Tsu, Mie-ken, 514-8507
Novartis Investigative Site
Tsukuba, Ibaraki, 3058576
Novartis Investigative Site
Wakayama, 640-8558
Novartis Investigative Site
Yokohama, Kanagawa, 231-8682
About this study
Official title: Fabhalta Capsules Specified Drug-use Survey(C3 Glomerulopathy, CLNP023B11401)
The objective of this study is to evaluate the safety and effectiveness of Fabhalta in patients with C3 glomerulopathy in clinical practice.
- Conditions
- C3 Glomerulopathy
- Keywords
- C3 glomerulopathy, C3G, Fabhalta
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 |
|---|---|---|
| iptacopan | patients administered iptacopan in clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with infections
Number of patients with infections and type of infections (meningococcal infection, pneumococcal infection, Haemophilus influenzae infection, and other infections based on the causative bacteria) as adverse events/adverse reactions during the treatment period
Measured: 360 Days
Secondary outcomes (7)
Incidence of adverse events and adverse reactions
Incidence of adverse events and adverse reactions that occurred during the treatment period
Measured: 360 Days
Changes in UPCR
Changes in UPCR from baseline to Day 360 and from baseline to 360 days
Measured: Baseline, 360 Days
Changes in eGFR
Changes in eGFR from baseline to Day 360 and from baseline to 360 days
Measured: Baseline, 360 Days
Proportion of patients achieving the composite renal endpoint at the final assessment.
The composite renal endpoint requirement will be met if the following criteria are met: (1) stable or improved eGFR relative to start of treatment (≤ 15% reduction in eGFR) and (2) decrease in UPCR by ≥ 50% relative to start of treatment. Initiation of a complement pathway modulator, initiation/intensification of corticosteroids or immunosuppressants (e.g., MMF) for C3 glomerulopathy, or renal replacement therapy will be determined as failure of the endpoint.
Measured: 360 Days
Changes in blood urea nitrogen (BUN)
Changes in blood urea nitrogen over the course of treatment
Measured: 360 Days
Changes in serum albumin
Changes in serum albumin over the course of treatment
Measured: 360 Days
Changes in serum creatinine
Changes in serum creatinine over the course of treatment
Measured: 360 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start17 Sep 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (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
- Cohort
- Time perspective
- Other
- Enrolment
- 33 participants (actual)
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
- NCT07156149
- Sponsor's protocol ID
- CLNP023B11401
- Status last verified
- Jul 2026
- First submitted
- 3 Sep 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fabhalta Capsules Specified Drug-use Survey(C3 Glomerulopathy, CLNP023B11401)
- ClinicalTrials.gov ID
- NCT07156149
- Acronym / sponsor ID
- CLNP023B11401
- Conditions
- C3 Glomerulopathy
- Keywords
- C3 glomerulopathy, C3G, Fabhalta
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 5 Sep 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 objective of this study is to evaluate the safety and effectiveness of Fabhalta in patients with C3 glomerulopathy in clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iptacopan | – | –patients administered iptacopan in clinical practice |
Who may qualify
- Ages
- 0 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who received Fabhalta.
Key inclusion criteria (1 listed)
- All patients who have used Fabhalta for C3 glomerulopathy (including patients with recurrent C3 glomerulopathy post renal transplant).
Key exclusion criteria (1 listed)
- Use of iptacopan for an indication not yet approved under the Clinical Trials Act or GCP (e.g., patient-requested medical treatment, investigator-initiated clinical trial)
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 patients with infections
Time frame: 360 Days
Number of patients with infections and type of infections (meningococcal infection, pneumococcal infection, Haemophilus influenzae infection, and other infections based on the causative bacteria) as adverse events/adverse reactions during the treatment period
7 secondary outcomes
Incidence of adverse events and adverse reactions
Time frame: 360 Days
Changes in UPCR
Time frame: Baseline, 360 Days
Changes in eGFR
Time frame: Baseline, 360 Days
Proportion of patients achieving the composite renal endpoint at the final assessment.
Time frame: 360 Days
Changes in blood urea nitrogen (BUN)
Time frame: 360 Days
Changes in serum albumin
Time frame: 360 Days
Changes in serum creatinine
Time frame: 360 Days
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 13 Jul 2026.
- 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. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
29 sites 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 29 sites in Japan.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Japan. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with infections (time frame: 360 Days). 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 13 Jul 2026.