Last Update: Aug 10, 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: [NCT07146906](https://clinicaltrials.gov/ct2/show/NCT07146906) Novartis Reference Number:CFUB523A12201 [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") 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). Condition Immunoglobulin A Nephropathy (IgAN) Phase Phase2 Overall Status Recruiting Number of Participants32 Start Date Mar 26, 2026 Completion Date Oct 18, 2030 Gender All Age(s) 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 \* 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. Brazil #### Novartis Investigative Site Recruiting Natal,Rio Grande do Norte,59012 300,Brazil #### Novartis Investigative Site Recruiting Recife,Pernambuco,50740-900,Brazil #### Novartis Investigative Site Recruiting Serra,Espírito Santo,29160-750,Brazil #### Novartis Investigative Site Recruiting Botucatu,São Paulo,3880-1001,Brazil China #### Novartis Investigative Site Recruiting Shanghai,200025,China #### Novartis Investigative Site Recruiting Beijing,100034,China Czechia #### Novartis Investigative Site Recruiting Prague,128 08,Czechia Germany #### Novartis Investigative Site Recruiting Mainz,55131,Germany #### Novartis Investigative Site Recruiting Hanover,30625,Germany #### Novartis Investigative Site Recruiting Munich,Bavaria,81377,Germany Italy #### Novartis Investigative Site Recruiting Pavia,PV,27100,Italy #### Novartis Investigative Site Recruiting Brescia,BS,25123,Italy #### Novartis Investigative Site Recruiting Ranica,BG,24020,Italy Japan #### Novartis Investigative Site Recruiting Kawasaki,Kanagawa,213-8587,Japan #### Novartis Investigative Site Recruiting Miyazaki,889-1692,Japan Poland #### Novartis Investigative Site Recruiting Lodz,92-213,Poland #### Novartis Investigative Site Recruiting Opole,45-401,Poland South Korea #### Novartis Investigative Site Recruiting Seoul,03722,South Korea #### Novartis Investigative Site Recruiting Seoul,Seoul,03080,South Korea Spain #### Novartis Investigative Site Recruiting Pamplona,Navarre,31008,Spain #### Novartis Investigative Site Recruiting Valencia,Valencia,46017,Spain #### Novartis Investigative Site Recruiting Barcelona,08036,Spain #### Novartis Investigative Site Recruiting Seville,41013,Spain Taiwan #### Novartis Investigative Site Recruiting Kaohsiung City,833,Taiwan #### Novartis Investigative Site Recruiting Taipei,10002,Taiwan United States #### Univ Of Iowa Hospitals And Clinics Recruiting Iowa City,Iowa,52242,United States ###### Lama Noureddine ###### Christine Zabawa Phone: [+1 319 356 1826]() Email: #### Inter Med Consultants Recruiting Edina,Minnesota,55435,United States ###### Jonathan Tolins ###### Charlene Newton Email: #### American Clinical Trials Recruiting Acworth,Georgia,30101,United States ###### Chinedu Nweke ###### Chidi Asuzu Email: #### Colorado Kidney Care Nephrology Recruiting Denver,Colorado,80230,United States ###### Leigh Collins Email: ###### Laura Kooienga ## Worldwide Contacts If the location of your choosing does not feature any contact detail, please reach out using the information below. #### Novartis Pharmaceuticals Phone: [ +41613241111](tel:+41613241111) Email: #### Novartis Pharmaceuticals Phone: [ 1-888-669-6682](tel:1-888-669-6682) Email: