Open-label Extension Study of Zigakibart in Adults With IgA Nephropathy. (NCT06858319) | Clinical Trial Compass
RecruitingPhase 3
Open-label Extension Study of Zigakibart in Adults With IgA Nephropathy.
United States220 participantsStarted 2025-07-28
Plain-language summary
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.
Who can participate
Age range18 Years – 100 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
✕. Received a live vaccination within 12 weeks prior to first study treatment administration in the OLE study or plan to have a live vaccination within 6 months after the last dose of study treatment.
✕. Use of systemic corticosteroid therapy (including budesonide) or other immunosuppressive therapy such as but not limited to mycophenolate, azathioprine, cyclosporine, tacrolimus, cyclophosphamide, etc., and herbs such as Tripterygium Wilfordii Hook F, Caulis sinomenii, and Sinomenium acutum for \> 2 weeks in the 12 weeks prior to first study treatment administration in the OLE study; use of rituximab within 180-days of first study treatment administration in the OLE study.
What they're measuring
1
Number of participants with adverse events.
Timeframe: Date of first administration of study treatment to 24 weeks after the date of the last actual administration of study treatment
2
Number of participants with serious adverse events.
Timeframe: Date of first administration of study treatment to 24 weeks after the date of the last actual administration of study treatment
3
Number of participants with adverse events of special interest.
Timeframe: Date of first administration of study treatment to 24 weeks after the date of the last actual administration of study treatment
✕. Current severe infection at the time of first study treatment in the OLE study or history of recurrent, severe, infections as determined by the Investigator.
✕. Newly diagnosed positive serology for hepatitis A virus IgM antibodies (anti-HAV IgM), hepatitis B surface antigen (HBsAg), detectable hepatitis B virus (HBV) DNA, hepatitis C virus (HCV) antibodies (participants who completed treatment and are persistently antibody positive but have documentation of negative HCV polymerase chain reaction \[PCR\] will be allowed), or antibodies to HIV-1 and/or HIV-2.