zigakibart: zigakibart 600 mg sc injections every second week for 104 weeks (2 years)
Study summary
The purpose of the study is to assess the effect of zigakibart on IgA nephropathy (IgAN) disease progression.
Eligibility
Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Change in mesangial IgA deposition — Baseline to Week 53 or 105 Change in mesangial IgA deposition as assessed by intensity of immunofluorescence staining
Trial sites (29)
Facility
City
Region
Status
Colorado Kidney Care Nephrology
Denver
Colorado
Recruiting
American Clinical Trials
Acworth
Georgia
Recruiting
Univ Of Iowa Hospitals And Clinics
Iowa City
Iowa
Recruiting
Inter Med Consultants
Edina
Minnesota
Recruiting
Novartis Investigative Site
Serra
Espírito Santo
Recruiting
Novartis Investigative Site
Recife
Pernambuco
Recruiting
Novartis Investigative Site
Natal
Rio Grande do Norte
Recruiting
Novartis Investigative Site
Botucatu
São Paulo
Recruiting
Novartis Investigative Site
Beijing
China
Recruiting
Novartis Investigative Site
Shanghai
China
Recruiting
Novartis Investigative Site
Prague
Czechia
Recruiting
Novartis Investigative Site
Munich
Bavaria
Recruiting
Novartis Investigative Site
Hanover
Germany
Recruiting
Novartis Investigative Site
Mainz
Germany
Recruiting
Novartis Investigative Site
Ranica
BG
Recruiting
Novartis Investigative Site
Brescia
BS
Recruiting
Novartis Investigative Site
Pavia
PV
Recruiting
Novartis Investigative Site
Kawasaki
Kanagawa
Recruiting
Novartis Investigative Site
Miyazaki
Japan
Recruiting
Novartis Investigative Site
Lodz
Poland
Recruiting
Novartis Investigative Site
Opole
Poland
Recruiting
Novartis Investigative Site
Seoul
Seoul
Recruiting
Novartis Investigative Site
Seoul
South Korea
Recruiting
Novartis Investigative Site
Pamplona
Navarre
Recruiting
Novartis Investigative Site
Valencia
Valencia
Recruiting
Novartis Investigative Site
Barcelona
Spain
Recruiting
Novartis Investigative Site
Seville
Spain
Recruiting
Novartis Investigative Site
Kaohsiung City
Taiwan
Recruiting
Novartis Investigative Site
Taipei
Taiwan
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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