Status:
NOT_YET_RECRUITING
A Study to Assess the Effects of Zigakibart on IgA Nephropathy.
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Immunoglobulin A Nephropathy (IgAN)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of the study is to assess the effect of zigakibart on IgA nephropathy (IgAN) disease progression.
Detailed Description
This is an open-label multicenter study where participants are randomized into one of two groups, where the only difference between the groups is the on-treatment biopsy time point, end of the first y...
Eligibility Criteria
Inclusion
- 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
- Secondary forms of IgAN, as determined by the Investigator, in the setting of systemic disorders, infections, autoimmune disorders or neoplasias
- Diagnosis of IgA vasculitis
- 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 immunosuppressive or other immunomodulatory agents within 52 weeks prior to Screening
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
November 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 16 2030
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT07146906
Start Date
November 18 2025
End Date
July 16 2030
Last Update
August 28 2025
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