Open-label Extension Study of Zigakibart in Adults With IgA Nephropathy.
A Multicenter Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Zigakibart in Adults With Primary IgA Nephropathy.
Sponsor: Novartis Pharmaceuticals
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
Request endpoint coverageKey Facts
Primary Endpoints (CT.gov)
Number of participants with adverse events.
Time frame: Date of first administration of study treatment to 24 weeks after the date of the last actual administration of study treatment
Number of participants with serious adverse events.
Time frame: Date of first administration of study treatment to 24 weeks after the date of the last actual administration of study treatment
Number of participants with adverse events of special interest.
Time frame: Date of first administration of study treatment to 24 weeks after the date of the last actual administration of study treatment
Secondary Endpoints
Change in UPCR from Baseline to Week 48 and Week 96.
Change in eGFR from Baseline to Week 96.
Change in eGFR from BEYOND parent study Baseline to Week 96 of OLE study.
Eligibility Criteria
Inclusion Criteria: 1. Signed informed consent must be obtained prior to participation in the OLE study. 2. Completion of the parent study (both participants assigned to receive the investigational product and placebo) as defined by the respective protocol. 3. Per Investigator's clinical judgment, the participant may benefit from receiving open-label treatment of zigakibart 600 mg s.c. Q2W. Exclusion Criteria: 1. Participants who prematurely withdrew from zigakibart parent studies in IgAN for any reason. 2. Participants who at the time of first study treatment administration in the OLE are receiving chronic dialysis (≥30 days) or who require kidney transplantation. 3. Acute kidney injury (AKI), defined by AKIN criteria (Mehta et al 2007) within 4 weeks of first study treatment administration in the OLE study. 4. Clinical suspicion or diagnosis of rapidly progressive glomerulonephritis (RPGN), defined by KDIGO guidelines, or another glomerulopathy at the time of first study treatment…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
Request coverage →