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

RecruitingPhase 2Ages 18 Years - anyAllNovartis Pharmaceuticals
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Primary IgAN, confirmed by kidney biopsy, within 5 years prior to Screening * eGFR โ‰ฅ45 mL/min/1.73 m2, based on the 2021 CKD-EPI equation, at Screening * Persistent proteinuria, defined as either * Total Urine Protein โ‰ฅ0.5 g/day or UPCR โ‰ฅ0.5 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 โ‰ฅ45 kg and body mass index (BMI) โ‰ค35.0 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.
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What it tests

  • zigakibart
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Where

30 sites
UC San Francisco Medical Center
San Francisco, United States
Colorado Kidney Care Nephrology
Denver, United States
American Clinical Trials
Acworth, United States
Univ Of Iowa Hospitals And Clinics
Iowa City, United States
Inter Med Consultants
Edina, United States
Novartis Investigative Site
Serra, Brazil
Novartis Investigative Site
Recife, Brazil
Novartis Investigative Site
Natal, Brazil

โ€ฆand 22 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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