Fabhalta Capsules Specified Drug-use Survey

Not yet recruiting

• Conditions: C3 Glomerulopathy

• Registration Number: NCT07156149
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

The objective of this study is to evaluate the safety and effectiveness of Fabhalta in patients with C3 glomerulopathy in clinical practice.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-03
• Study First Submitted QC: 2025-09-03
• Last Update Submitted: 2025-09-03
• Study First Posted: 2025-09-05
• Last Update Posted: 2025-09-05
• Study Start: 2025-09-30
• Primary Completion: 2028-06-30
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with infections	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

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events and adverse reactions	360 Days	Incidence of adverse events and adverse reactions that occurred during the treatment period
Changes in UPCR	Baseline, 360 Days	Changes in UPCR from baseline to Day 360 and from baseline to 360 days
Changes in eGFR	Baseline, 360 Days	Changes in eGFR from baseline to Day 360 and from baseline to 360 days
Changes in serum creatinine	360 Days	Changes in serum creatinine over the course of treatment
Changes in blood urea nitrogen (BUN)	360 Days	Changes in blood urea nitrogen over the course of treatment
Proportion of patients achieving the composite renal endpoint at the final assessment.	360 Days	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.
Changes in serum albumin	360 Days	Changes in serum albumin over the course of treatment