A Study to Assess the Effects of Zigakibart on IgA Nephropathy.

Recruiting now · Phase 2

Conditions studied: Immunoglobulin A Nephropathy (IgAN)

In brief

The purpose of the study is to assess the effect of zigakibart on IgA nephropathy (IgAN) disease progression.

Key facts

Study ID

NCT07146906

Run by

Novartis Pharmaceuticals

People needed

32

Starts

2026-03-26

Expected to finish

2030-10-18

Last updated by the study team

2026-06-23

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Secondary forms of IgAN, as determined by the Investigator, diagnosis of IgA vasculitis, or any other nephropathy or chronic urinary tract disorder
• Total IgG <6.0 g/L at screening
• Any chronic urinary tract disorder, including but not limited to retention, incontinence, and/or recurrent urinary tract infections
• An average systolic blood pressure >150 mmHg or average diastolic blood pressure >90 mmHg based on three measurements at Screening
• 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.

Where it is running

• Colorado Kidney Care Nephrology — Denver, Colorado, United States (enrolling)
• American Clinical Trials — Acworth, Georgia, United States (enrolling)
• Univ Of Iowa Hospitals And Clinics — Iowa City, Iowa, United States (enrolling)
• Inter Med Consultants — Edina, Minnesota, United States (enrolling)
• Novartis Investigative Site — Serra, Espírito Santo, Brazil (enrolling)
• Novartis Investigative Site — Botucatu, São Paulo, Brazil (enrolling)
• Novartis Investigative Site — Beijing, China (enrolling)
• Novartis Investigative Site — Shanghai, China (enrolling)
• Novartis Investigative Site — Munich, Bavaria, Germany (enrolling)
• Novartis Investigative Site — Hanover, Germany (enrolling)
• Novartis Investigative Site — Mainz, Germany (enrolling)
• Novartis Investigative Site — Ranica, BG, Italy (enrolling)
• Novartis Investigative Site — Brescia, BS, Italy (enrolling)
• Novartis Investigative Site — Pavia, PV, Italy (enrolling)
• Novartis Investigative Site — Kawasaki, Kanagawa, Japan (enrolling)
• Novartis Investigative Site — Miyazaki, Japan (enrolling)
• Novartis Investigative Site — Lodz, Poland (enrolling)
• Novartis Investigative Site — Opole, Poland (enrolling)
• Novartis Investigative Site — Seoul, Seoul, South Korea (enrolling)
• Novartis Investigative Site — Seoul, South Korea (enrolling)
• Novartis Investigative Site — Pamplona, Navarre, Spain (enrolling)
• Novartis Investigative Site — Valencia, Valencia, Spain (enrolling)
• Novartis Investigative Site — Barcelona, Spain (enrolling)
• Novartis Investigative Site — Seville, Spain (enrolling)
• Novartis Investigative Site — Kaohsiung City, Taiwan (enrolling)

Full record on ClinicalTrials.gov

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