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.

CT.gov Identifier
NCT07146906
EudraCT Identifier
2024-519699-24
CTIS:
N/A
Sponsor
Novartis
Collaborator
N/A
Study Contact Information
+41 61 324 0000
Recruiting
Contact Us

Study Details

Diseases
IgA nephropathy
Study Drug
Zigakibart
Genes
N/A
Study Dates
Mar 2026 - Jul 2030
Sex
Female & Male
Age
18 - 100 Years
Inclusion and Exclusion 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 screeningAny chronic urinary tract disorder, including but not limited to retention, incontinence, and/or recurrent urinary tract infectionsUntreated 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 screeningAcute kidney injury (AKI), defined by AKI network criteria, within 4 weeks prior to screeningCurrent 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 screeningPlanned initiation of, or recently (within 24 weeks) initiated, treatment with glucagon-like peptide-1 agonists at screeningOther protocol-defined inclusion/exclusion criteria may apply.

Protocol Summary

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

Study Locations

To view all trial locations, click here

Contact Us About More Information for the Clinical Trial Concierge Service

Natera’s Clinical Trial Concierge Program is comprised of a dedicated team that helps connect providers and patients with appropriate clinical trials. To learn more about a trial offered through this service, please complete the form below.  

Fields marked with asterisk (*) are mandatory.

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.