A Study of the Efficacy and Safety of Zigakibart + Atrasentan in Adult Patients With Primary IgA Nephropathy
brief summary
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.
detailed description
The study includes a 52-week double-blind treatment period and a 52-week open-label extension (OLE):
* Double-blind treatment period: Participants will receive zigakibart and either atrasentan or matching placebo. The purpose is to evaluate if zigakibart + atrasentan demonstrates increased efficacy in reducing proteinuria and delaying progression of disease compared to zigakibart + placebo. It also aims to evaluate the safety and tolerability of zigakibart + atrasentan. * OLE: Participants will receive zigakibart and atrasentan. The purpose is to provide study participants with the opportunity to continue to receive zigakibart and atrasentan, while enabling continued collection of long-term efficacy, safety, and tolerability data.
official title
A Phase IIIb, Multi-center, Two-arm, Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Zigakibart and Atrasentan Versus Zigakibart and Placebo in Patients With Primary IgA Nephropathy