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

RecruitingPhase 2

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.

Who can join

Ages 18 to 100 · All sexes

Full 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.

About the study

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

What is being tested

Sponsor: Novartis Pharmaceuticals · Participants: 32 · Started: Mar 26, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07146906

Locations in the U.S.

ColoradoColorado Kidney Care Nephrology, Denver
GeorgiaAmerican Clinical Trials, Acworth
IowaUniv Of Iowa Hospitals And Clinics, Iowa City
MinnesotaInter Med Consultants, Edina

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.