IgA nephropathy
Conditions
Brief summary
Type, incidence, severity, seriousness, and relatedness of treatment-emergent adverse events (TEAEs), Incidence, severity, seriousness, and relatedness of adverse events of special interest (AESI)
Detailed description
Change from Baseline to Weeks 48 and 96 in UPCR based on 24h-urine collection, Change from Baseline to Week 96 in eGFR, using the chronic kidney disease-epidemiology collaboration (CKD-EPI) creatinine equation, Change from BEYOND parent study Baseline to Week 96 of OLE study in eGFR, Serum concentrations of zigakibart, Changes from baseline in immunoglobulin levels, Presence of circulating binding and neutralizing antidrug antibodies (ADA/Nab), Safety laboratory parameters and vital signs
Interventions
DRUGBion 1301/FUB523
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Type, incidence, severity, seriousness, and relatedness of treatment-emergent adverse events (TEAEs), Incidence, severity, seriousness, and relatedness of adverse events of special interest (AESI) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline to Weeks 48 and 96 in UPCR based on 24h-urine collection, Change from Baseline to Week 96 in eGFR, using the chronic kidney disease-epidemiology collaboration (CKD-EPI) creatinine equation, Change from BEYOND parent study Baseline to Week 96 of OLE study in eGFR, Serum concentrations of zigakibart, Changes from baseline in immunoglobulin levels, Presence of circulating binding and neutralizing antidrug antibodies (ADA/Nab), Safety laboratory parameters and vital signs | — |
Outcome results
None listed