The purpose of this study is to determine if zigakibart is safe and effective for long-term use in patients with immunoglobulin A nephropathy (IgAN). This is an extension study for patients who have already completed an another zigakibart study.
Signed informed consent must be obtained prior to participation in the OLE study.
Completion of the parent study (both participants assigned to receive the investigational product and placebo) as defined by the respective protocol.
Per Investigator's clinical judgment, the participant may benefit from receiving open-label treatment of zigakibart 600 mg s.c. Q2W.
Participants who prematurely withdrew from zigakibart parent studies in IgAN for any reason.
Participants who at the time of first study treatment administration in the OLE are receiving chronic dialysis (≥30 days) or who require kidney transplantation.
Acute kidney injury (AKI), defined by AKIN criteria (Mehta et al 2007) within 4 weeks of first study treatment administration in the OLE study.
Clinical suspicion or diagnosis of rapidly progressive glomerulonephritis (RPGN), defined by KDIGO guidelines, or another glomerulopathy at the time of first study treatment administration in the OLE study.
Single group
zigakibart
Drugsolution for subcutaneous injection
Number of participants with adverse events.
Number of participants with adverse events will be provided.
Number of participants with serious adverse events.
Number of participants with serious adverse events will be provided.
Number of participants with adverse events of special interest.
Number of participants with adverse events of special interest will be provided.
Change in UPCR from Baseline to Week 48 and Week 96.
The change in the ratio of urine protein to urine creatinine (UPCR), based on 24-hour urine collection, from Baseline to Week 48 and to Week 96.
Change in eGFR from Baseline to Week 96.
Estimated glomerular filtration rate (eGFR) will be calculated using the chronic kidney disease-epidemiology collaboration (CKD-EPI) creatinine equation. The change (difference) in eGFR between Baseline and Week 96 timepoints will then be calculated.
Change in eGFR from BEYOND parent study Baseline to Week 96 of OLE study.
eGFR will be calculated using the chronic kidney disease-epidemiology collaboration (CKD-EPI) creatinine equation. The change (difference) in eGFR between Baseline in the BEYOND study and Week 96 in OLE study will then be calculated.
Serum concentration values of zigakibart at scheduled visits.
Serum concentration values will be provided for the following scheduled visits: Day 1, Week 24 and Week 96.
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