IgAN is an autoimmune kidney disease that occurs when clumps of immunoglobulin A and antibodies are deposited in the kidneys, causing inflammation and kidney damage which leads to blood and protein leaking into the urine.2 

The Health Canada authorization is based on a prespecified interim analysis results at 36 weeks of the Phase III ALIGN study, a randomized, double-blind, placebo-controlled study in adults ≥ 18 years with biopsy-proven primary IgAN, estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m² and total urine protein ≥ 1 g/day who were on a stable dose of maximally tolerated renin-angiotensin system inhibitor therapy.¹