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
- Barcelona, Pamplona, Sevilla, and Valencia, SpainSee the 4 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with primary IgA nephropathy confirmed by kidney biopsy, who still have protein in the urine and fairly good kidney function.
- Age
- 18 years or older.
- Sex
- All sexes can join.
- Disease stage
- Primary IgA nephropathy confirmed by kidney biopsy within 5 years before screening. eGFR ≥45 mL/min/1.73 m2. Ongoing protein in the urine: total urine protein ≥0.5 g/day or UPCR ≥0.5 g/g despite supportive therapy, or a diagnosis less than 6 months ago with total urine protein >1.5 g/day or UPCR >1.5 g/g.
- Earlier treatment
- People cannot have had complement pathway inhibitors, mycophenolic acids, systemic calcineurin inhibitors, corticosteroids or immunosuppressive or immunomodulatory agents within 12 months before screening. People cannot have had anti-APRIL antibodies or dual APRIL/BAFF inhibitors for more than 3 months in a row. Those with persistent protein in urine must have had the maximally tolerated dose of supportive therapy, or poorly tolerated supportive therapy.
- Biomarker or test result
- Total urine protein ≥0.5 g/day or UPCR ≥0.5 g/g in a 24-hour urine collection. Body weight ≥45 kg (99 lb) and BMI ≤35.0 kg/m2.
Main reasons for not taking part
- IgAN caused by another condition, IgA vasculitis, or any other kidney disease
- Total IgG <6.0 g/L at screening
- Any long-term urinary tract problem, such as retention, incontinence or repeated urinary infections
- Average blood pressure above 150 mmHg (top number) or 90 mmHg (bottom number)
- Acute kidney injury within 4 weeks before screening
Read by machine on 9 November 2026.
Where in Spain
- Hospital Clinic de BarcelonaBarcelona, SpainTaking people
- Clínica Universidad de navarraPamplona, SpainTaking people
- University Hospital Virgen Del Rocio S.L.Sevilla, SpainTaking people
- Hospital Universitario Dr. Peset AleixandreValencia, SpainTaking 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.