Phase 2/3, Multicenter, Open-label Trial to Evaluate the Long-term Safety, Tolerability, and Efficacy of Sibeprenlimab Administered Subcutaneously in Subjects with Immunoglobulin A Nephropathy
Phase 2
Recruiting
- Conditions
- Immunoglobulin A Nephropathy
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 600
Inclusion Criteria
1. 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
2.eGFR >20 mL/min/1.73 m2, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
Exclusion Criteria
1.Subjects who have not completed participation in trials 417-201-00007 or VIS649-201.
2.Subjects with treatment-limiting adverse events (AEs) during Trials 417-201-00007 or VIS649-201 considered related to IMP per investigator judgement that would preclude rollover into this trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method