Date

2025-01-22

Protocol

Protocol changed

Item Changed

Secondary outcome(s)

Previous Version

1.Annualized slope of Estimated Glomerular Filtration Rate (eGFR) Urine protein/creatinine ratio (uPCR) in a 24-hour collection Proportion of Subjects with Clinical Remission as defined in the protocol Time to Progression of Chronic Kidney Disease, as defined in the protocol (available to download under supporting documents) [Annualized slope of Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: Over 12 and 24 months ] Urine protein/creatinine ratio (uPCR) in a 24-hour collection [ Time Frame: At 12 and 24 months ] Proportion of Subjects with Clinical Remission as defined in the protocol [ Time Frame: At 12 and 24 months ] Time to Progression of Chronic Kidney Disease, as defined in the protocol [ Time Frame: Over 24 months ]]

Next Version

Efficacy: • To evaluate the long-term efficacy of sibeprenlimab in subjects with IgAN. • To evaluate the treatment effect of sibeprenlimab on the progression to a composite kidney failure endpoint (as measured by time to event or proportion of subjects). Pharmacodynamics: • To evaluate Ig response in subjects with IgAN. Other: • To evaluate immunogenicity in subjects with IgAN. 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.