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Recruiting
NCT07146906
A Study to Assess the Effects of Zigakibart on IgA Nephropathy.
Conditions: Immunoglobulin A Nephropathy (IgAN)
Sex: All
Ages: 18 Years – 100 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 32
Sponsor: Novartis Pharmaceuticals
Location: Colorado Kidney Care Nephrology Denver Colorado
Summary
The purpose of the study is to assess the effect of zigakibart on IgA nephropathy (IgAN) disease progression.
Eligibility Criteria
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 \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 \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.
Source: ClinicalTrials.gov (NCT07146906). StuddyBuddy aggregates publicly available trial information.