A multi-center, double-blinded, randomized controlled trial involving 199 biopsy-proven, proteinuric (>0.8g/g) IgAN patients between 23-73 years old and eGFR between 35-90 on optimized ACE who were randomized to either oral budesonide 16mg daily or placebo. The primary endpoint was 24 hour urine protein-to-creatinine ratio (UPCR) after 9 months. The secondary endpoint was decline in eGFR at 9 months and 12 months and change in proteinuria at 12 months. The study found that treatment patients had 27% lower proteinuria than control at 9 months as well as preservation of eGFR with an average of 3.8mL/min. Adverse events in the treatment group were characterized mild-moderate and included hypertension, peripheral edema, spasms, and acne.
