Last Update: Apr 01, 2026
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.
ClinicalTrials.gov Identifier:
Novartis Reference Number:CFUB523A12201
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

The purpose of the study is to assess the effect of zigakibart on IgA nephropathy (IgAN) disease progression. This is an open-label multicenter study where participants are randomized into one of two groups, where the only difference between the groups is the on-treatment biopsy time point, end of the first year of treatment (Group A) or at the end of the second year of treatment (Group B).

The total study duration for each participant may be up to 125 weeks, including the maximum screening period (8 weeks), the treatment period (104 weeks), and the safety follow up period (13 weeks).

Immunoglobulin A Nephropathy (IgAN)
Phase2
Recruiting
32
Mar 26, 2026
Oct 18, 2030
All
18 Years - 100 Years (Adult, Older Adult)

Interventions

Biological

zigakibart

zigakibart 600 mg sc injections every second week for 104 weeks (2 years)

Eligibility Criteria

Inclusion Criteria:

* 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 Criteria:

* 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
* Untreated hypertension or uncontrolled hypertension despite treatment (i.e., resistant hypertension)
* 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.

Novartis Investigative Site

Recruiting

Shanghai,200025,China

Novartis Investigative Site

Recruiting

Kawasaki,Kanagawa,213-8587,Japan

Novartis Investigative Site

Recruiting

Miyazaki,889-1692,Japan

Novartis Investigative Site

Recruiting

Seoul,Korea,03080,South Korea

Novartis Investigative Site

Recruiting

Taipei,10002,Taiwan

Colorado Kidney Care Nephrology

Recruiting

Denver,Colorado,80230,United States

Laura Kooienga
Leigh Collins

American Clinical Trials

Recruiting

Acworth,Georgia,30101,United States

Chidi Asuzu
Chinedu Nweke

Inter Med Consultants

Recruiting

Edina,Minnesota,55435,United States

Andrew Tran
Jonathan Tolins

Worldwide Contacts

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Novartis Pharmaceuticals

Novartis Pharmaceuticals