This is a Phase IIIb, multicenter, two-arm, randomized, double-blind, parallel group study to evaluate the efficacy and safety of zigakibart + atrasentan compared to zigakibart + placebo in patients with primary IgAN at risk of disease progression.
Aged ≥ 18 years at the time of signing the informed consent, prior to initiation of any study specific activities/procedures
Biopsy-proven IgAN diagnosed within the past 10 years prior to Screening, that, in the opinion of the Investigator, is not due to secondary causes. If a biopsy report within 10 years is not available, re-biopsy may be performed locally during Screening.
eGFR ≥ 30 mL/min/1.73m2 by a central laboratory at Screening, calculated using serum creatinine based on the 2021 CKD-EPI equation (Inker et al 2021)
UPCR ≥ 0.7 g/g (700 mg/g), as measured from a 24 hour urine collection by a central laboratory at Screening
Chronic Kidney Disease (CKD), either clinically suspected or based on biopsy, resulting from any condition or another glomerulopathy/podocytopathy other than IgAN
Secondary forms of IgAN as determined by the Investigator, in the setting of systemic disorders, infections, autoimmune disorders or neoplasia
Diagnosis of active IgA vasculitis
Clinical suspicion of IgAN with rapidly progressive glomerulonephritis (RPGN) based on Kidney Disease: Improving Global Outcomes (KDIGO) guidelines (2025)
Parallel
zigakibart
Biological/VaccineSolution for injection via PFS-NSD
atrasentan
DrugTablet
Placebo
DrugTablet
Change in proteinuria from Baseline to Week 36, based on 24 hour urine collection
Relative difference between treatment groups in mean change of natural log 24-hour UPCR from Baseline to Week 36, expressed as percent reduction
Rate of patients achieving proteinuria remission at Week 52
Difference between the treatment groups in the rate of patients achieving proteinuria remission, defined as 24-hour UPCR \< 0.5 g/g
Rate of proteinuria remission
Difference between the treatment groups in the rate of proteinuria remission, defined as 24-hour UPCR of \< 0.3 g/g
Proportion of participants with AEs, SAEs and AESIs
Proportion of participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of special interest (AESIs)
Change from baseline in Glomerular Filtration rate (GFR)
Change from baseline in GFR (safety laboratory parameters)
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This trial is not recruiting at the moment. You can still explore other options:
