Date

2025-01-22

Protocol

Protocol changed

Item Changed

Inclusion criteria

Previous Version

Subjects who completed Trial 417-201-00007;NCT05248646 (at least 20 of the 26 doses and the end-of-trial visit) or Trial VIS649-201;NCT04287985 (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 eGFR >20 mL/min/1.73 m2, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.

Next Version

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.