Date

2026-07-10

Protocol

Protocol changed

Item Changed

Inclusion criteria

Previous Version

Inclusion criteria 1) Subjects who completed Trial 417-201-00007 (at least 20 of the 26 doses and the end-of-trial visit) or Trial VIS649-201 (at least 9 of the 12 doses and the end-of-trial visit) without safety concerns and who, in the opinion of the investigator, could potentially benefit from treatment with sibeprenlimab for IgAN. 2) Subject has eGFR ? 20 mL/min/1.73 m2 , calculated using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine eGFR formula. 3) Ability to provide written, informed consent prior to initiation of any trial-specific procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial.

Next Version

1) Subjects who completed Trial 417-201-00007 (at least 20 of the 26 doses over a 2-year duration and the end-of-trial visit) or Trial VIS649-201 (at least 9 of the 12 doses over a 1-year duration and the end-of-trial visit) without safety concerns and who, in the opinion of the investigator, could potentially benefit from treatment with sibeprenlimab for IgAN. 2) (Criterion deleted by Protocol Amendment 3) 3) Ability to provide written, informed consent prior to initiation of any trial-specific procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial.