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Active, not recruiting

NCT Number: NCT07156149

Fabhalta Capsules Specified Drug-use Survey

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

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

C3 Glomerulopathy

Age range

0 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Nagoya, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Incidence of adverse events and adverse reactions

    Time frame: 360 Days

    Incidence of adverse events and adverse reactions that occurred during the treatment period

  2. Changes in UPCR

    Time frame: Baseline, 360 Days

    Changes in UPCR from baseline to Day 360 and from baseline to 360 days

  3. Changes in eGFR

    Time frame: Baseline, 360 Days

    Changes in eGFR from baseline to Day 360 and from baseline to 360 days

  4. Proportion of patients achieving the composite renal endpoint at the final assessment.

    Time frame: 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.

  5. Changes in blood urea nitrogen (BUN)

    Time frame: 360 Days

    Changes in blood urea nitrogen over the course of treatment

  6. Changes in serum albumin

    Time frame: 360 Days

    Changes in serum albumin over the course of treatment

  7. Changes in serum creatinine

    Time frame: 360 Days

    Changes in serum creatinine over the course of treatment

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 5, 2025
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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