Fabhalta capsules: real-world use in C3 glomerulopathy

Fabhalta Capsules Specified Drug-use Survey(C3 Glomerulopathy, CLNP023B11401)

This survey will see how Fabhalta works and how safe it is in people with C3 glomerulopathy who have already taken the medicine in routine care.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 0 Years to 100 Years
• Sex: All
• Sponsor: Novartis (Industry-sponsored)
• Locations: 26 sites (Nagoya, Aichi-ken and 25 other locations)
• Trial ID: NCT07156149 on ClinicalTrials.gov

What this trial studies

This is an observational drug-use survey collecting safety and outcome information from patients with C3 glomerulopathy who have been treated with Fabhalta in routine clinical practice. Data will be gathered at Novartis investigative sites in Japan and will include patients with recurrent C3 glomerulopathy after kidney transplant. No experimental interventions are administered as part of the survey; the study records real-world treatment patterns, adverse events, and clinical course. Patients who received iptacopan for indications not approved under applicable regulations or within certain trial contexts are excluded.

Who should consider this trial

Good fit: People with C3 glomerulopathy who have already used Fabhalta, including those with recurrent disease after kidney transplant, are eligible.

Not a fit: Patients who have never taken Fabhalta or who used iptacopan for unapproved indications will not be eligible and are unlikely to benefit from this survey.

Why it matters

Potential benefit: If successful, the results could help clinicians and patients understand the real-world safety and potential benefits of Fabhalta for C3 glomerulopathy.

How similar studies have performed: Clinical trials of iptacopan have shown promising signals in complement-mediated kidney disease, but real-world drug-use surveys specifically describing Fabhalta use in C3 glomerulopathy remain limited.

Eligibility criteria

Inclusion Criteria:

* All patients who have used Fabhalta for C3 glomerulopathy (including patients with recurrent C3 glomerulopathy post renal transplant).

Exclusion Criteria:

* 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)

Where this trial is running

Nagoya, Aichi-ken and 25 other locations

• Novartis Investigative Site — Nagoya, Aichi-ken, Japan (Recruiting)
• Novartis Investigative Site — Toyoake, Aichi-ken, Japan (Recruiting)
• Novartis Investigative Site — Hirosaki, Aomori, Japan (Recruiting)
• Novartis Investigative Site — Chiba, Chiba, Japan (Recruiting)
• Novartis Investigative Site — Kitakyushu, Fukuoka, Japan (Recruiting)
• Novartis Investigative Site — Sapporo, Hokkaido, Japan (Recruiting)
• Novartis Investigative Site — Sapporo, Hokkaido, Japan (Recruiting)
• Novartis Investigative Site — Tsukuba, Ibaraki, Japan (Active_not_recruiting)
• Novartis Investigative Site — Komatsu, Ishikawa-ken, Japan (Active_not_recruiting)
• Novartis Investigative Site — Tsu, Mie-ken, Japan (Active_not_recruiting)
• Novartis Investigative Site — Nagasaki, Nagasaki, Japan (Recruiting)
• Novartis Investigative Site — Shimajiri-Gun, Okinawa, Japan (Recruiting)
• Novartis Investigative Site — Suita, Osaka, Japan (Recruiting)
• Novartis Investigative Site — Takatsuki, Osaka, Japan (Active_not_recruiting)
• Novartis Investigative Site — Kusatsu, Shiga, Japan (Recruiting)
• Novartis Investigative Site — Ohtsu, Shiga, Japan (Recruiting)
• Novartis Investigative Site — Shimotsuga Gun, Tochigi, Japan (Recruiting)
• Novartis Investigative Site — Tokushima, Tokushima, Japan (Recruiting)
• Novartis Investigative Site — Bunkyo-ku, Tokyo, Japan (Active_not_recruiting)
• Novartis Investigative Site — Fuchū, Tokyo, Japan (Recruiting)
• Novartis Investigative Site — Nakano City, Tokyo, Japan (Recruiting)
• Novartis Investigative Site — Shinjuku Ku, Tokyo, Japan (Recruiting)
• Novartis Investigative Site — Yosa, Yosa, Japan (Active_not_recruiting)
• Novartis Investigative Site — Hiroshima, Japan (Recruiting)
• Novartis Investigative Site — Nara, Japan (Active_not_recruiting)
• Novartis Investigative Site — Wakayama, Japan (Active_not_recruiting)

Study contacts

• Study coordinator: Novartis Pharmaceuticals

Conditions C3 Glomerulopathy; C3 glomerulopathy; C3G; Fabhalta