Tests zigakibart in adults with IgA nephropathy, a kidney disease
Tests zigakibart in adults with IgA nephropathy, a kidney disease that progresses over time.
Plain-language title generated from the registry record
Registry title: A Study to Assess the Effects of Zigakibart on IgA Nephropathy.
Key facts
- Where
- Botucatu, Natal, Recife, and Serra, BrazilSee the 4 sites
- Phase
- Phase 2
Where in Brazil
- BotucatuBotucatu, BrazilTaking people
- NatalNatal, BrazilTaking people
- RecifeRecife, BrazilTaking people
- SerraSerra, BrazilTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novartis Pharmaceuticals
- Trial code
- NCT07146906EU 2024-519699-24-00
- Record updated
- 21 October 2026
- Original description
The purpose of the study is to assess the effect of zigakibart on IgA nephropathy (IgAN) disease progression.Read full original descriptionShow less
An Open-label, Multicenter Study to Assess the Effect of Zigakibart Treatment on Histologic, Circulating, and Excreted Markers of Kidney Disease and Dysfunction in Adult Patients With IgA Nephropathy.
The purpose of the study is to assess the effect of zigakibart on IgA nephropathy (IgAN) disease progression.
Inclusion: Primary IgAN, confirmed by kidney biopsy, within 5 years prior to Screening; eGFR ≥45 mL/min/1.73 m2, based on the 2021 CKD-EPI equation, at Screening; Persistent proteinuria, defined as either; Total Urine Protein ≥0.5 g/day or UPCR ≥0.5 g/g in a 24-hour urine collection, at Screening, despite maximally tolerated dose or poorly tolerated supportive therapy or; IgAN diagnosis <6 months prior to Screening with Total Urine Protein >1.5 g/day or UPCR >1.5 g/g in a 24-hour urine collection, at the time of clinical presentation or diagnosis; Body weight ≥45 kg and body mass index (BMI) ≤35.0 kg/m2, at Screening.
Exclusion: Treatment with complement pathway inhibitors, mycophenolic acids, systemic calcineurin inhibitors or corticosteroids, immunosuppressive or immunomodulatory agents within 12 months prior to screening; Acute kidney injury (AKI), defined by AKI network criteria, within 4 weeks prior to screening; Current treatment with anti-APRIL monoclonal antibodies or dual APRIL/BAFF inhibitors or past treatment of the same at any time for >3 consecutive months prior to screening; Planned initiation of, or recently (within 24 weeks) initiated, treatment with glucagon-like peptide-1 agonists at screening; Other protocol-defined inclusion/exclusion criteria may apply; Secondary forms of IgAN, as determined by the Investigator, diagnosis of IgA vasculitis, or any other nephropathy or chronic urinary tract disorder; Any chronic urinary tract disorder, including but not limited to retention, incontinence, and/or recurrent urinary tract infections; Total IgG <6.0 g/L at screening; An average systolic blood pressure >150 mmHg or average diastolic blood pressure >90 mmHg based on three measurements at Screening.