APPLAUSE-IgAN
Iptacopan in Primary IgA Nephropathy
Patient / Population Intervention / Exposure Comparison Outcome
In 250 patients with IgA nephropathy and persistent proteinuria, the factor-B inhibitor iptacopan reduced proteinuria compared with placebo.
N
250
Design
Phase 3 double-blind RCT
Endpoint
Reduction in 24-hour UPCR (month-9 interim); annualised eGFR slope
Relevance
3
Result38.3% greater UPCR reduction versus placebo (p<0.0001); 2-year data met the eGFR-slope endpoint.
Perkovic V, et al. N Engl J Med. 2025;392(6):531-543. 10.1056/NEJMoa2410316
Discussion & critique
First complement factor-B inhibitor for IgA nephropathy; accelerated FDA approval of Fabhalta in 2024.