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Clinical Trials in China / NCT07146906
Recruiting Phase 2

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

NCT07146906 · tracked via the Priya Life Science China tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 2
Started
2026-03-26
Last updated
2026-08-10

Condition(s) studied

Immunoglobulin A Nephropathy (IgAN)

Investigational drug(s) / intervention(s)

zigakibart

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)

Trial sites (29)

FacilityCityRegionStatus
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

More Novartis Pharmaceuticals trials in China

Other trials for the same condition

Official registry record

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.

View NCT07146906 on ClinicalTrials.gov ↗ ← All trials in China