RecruitingPhase 2NCT07146906
A Study to Assess the Effects of Zigakibart on IgA Nephropathy.
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.
Sponsor
Novartis Pharmaceuticals
Enrollment
32 participants
Start Date
Mar 26, 2026
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of the study is to assess the effect of zigakibart on IgA nephropathy (IgAN) disease progression.
Eligibility
Min Age: 18 YearsMax Age: 100 Years
Inclusion Criteria6
- 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 Criteria8
- 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
- Untreated 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 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
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Interventions
BIOLOGICALzigakibart
zigakibart 600 mg sc injections every second week for 104 weeks (2 years)
Locations(8)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07146906