Date

2026-07-10

Protocol

Protocol changed

Item Changed

Secondary outcome(s) - Time of assessment(s)

Previous Version

Efficacy: · The slope of eGFR over the course of approximately 12 and 24 months. · Mean change of eGFR from baseline at 12 and 24 months. · Estimate the time-normalized area under curve (AUC) for eGFR at 12 and 24 months. · Relative change from baseline in terms of uPCR at 12 and 24 months, based on 24-hour urine collection. · Overall rate of proteinuric remission, based on 24-hour urine collection, and defined as the proportion of subjects achieving urine total protein < 0.5 g/day at 12 and 24 months. · Time to progression to a composite kidney failure endpoint defined as the time to the first occurrence of any of the following: a doubling of serum creatinine, 40% reduction in eGFR, eGFR < 15 mL/min/1.73 m2 , or the requirement of renal replacement therapy (chronic dialysis for >= 4 weeks or kidney transplantation). · Progression to a composite kidney failure endpoint measured as the proportion of subjects who meet at least one of the following: a doubling of serum creatinine, 40% reduction in eGFR, eGFR < 15 mL/min/1.73 m2 , or the requirement of renal replacement therapy (chronic dialysis for >= 4 weeks or kidney transplantation) over the course of 24 months. Pharmacodynamics: Change from baseline in total serum IgA, IgG, and IgM concentrations. Other: Evaluation of serum ADA levels.

Next Version

• The slope of eGFR, mean change of eGFR from baseline, the time-normalized AUC for eGFR, relative change from baseline of uPCR and overall rate of proteinuric remission - at 12 and 24 months. • Progression to CKF as assessed by sustained doubling of serum creatinine compared with baseline based on 2 measurements at least 4 weeks apart