The objective of this study is to evaluate the safety and effectiveness of Fabhalta in patients with C3 glomerulopathy in clinical practice.
Study Type
OBSERVATIONAL
Enrollment
50
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
RECRUITINGNovartis Investigative Site
Sapporo, Hokkaido, Japan
RECRUITINGNumber 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
Time frame: 360 Days
Incidence of adverse events and adverse reactions
Incidence of adverse events and adverse reactions that occurred during the treatment period
Time frame: 360 Days
Changes in UPCR
Changes in UPCR from baseline to Day 360 and from baseline to 360 days
Time frame: Baseline, 360 Days
Changes in eGFR
Changes in eGFR from baseline to Day 360 and from baseline to 360 days
Time frame: 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.
Time frame: 360 Days
Changes in blood urea nitrogen (BUN)
Changes in blood urea nitrogen over the course of treatment
Time frame: 360 Days
Changes in serum albumin
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Novartis Investigative Site
Sapporo, Hokkaido, Japan
RECRUITINGNovartis Investigative Site
Komatsu, Ishikawa-ken, Japan
RECRUITINGNovartis Investigative Site
Tsu, Mie-ken, Japan
RECRUITINGNovartis Investigative Site
Takatsuki, Osaka, Japan
RECRUITINGNovartis Investigative Site
Kusatsu, Shiga, Japan
RECRUITINGNovartis Investigative Site
Ohtsu, Shiga, Japan
RECRUITINGNovartis Investigative Site
Fuchū, Tokyo, Japan
RECRUITINGNovartis Investigative Site
Shinjuku Ku, Tokyo, Japan
RECRUITING...and 1 more locations
Changes in serum albumin over the course of treatment
Time frame: 360 Days
Changes in serum creatinine
Changes in serum creatinine over the course of treatment
Time frame: 360 Days