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A Study to Assess the Effects of Zigakibart on IgA Nephropathy.
A Study to Assess the Effects of Zigakibart on IgA Nephropathy.
RecruitingPhase 2
Sponsor: Novartis Pharmaceuticals
Conditions: Immunoglobulin A Nephropathy (IgAN)
Interventions: zigakibart
Countries: United States, Brazil, China, Czechia, Germany, Italy, Japan, Poland
The purpose of the study is to assess the effect of zigakibart on IgA nephropathy (IgAN) disease progression.
Eligibility overview
Sex: ALL
Age: 18 Years to 100 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
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 \<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.
Locations (29)
- Denver, Colorado, United States
- Acworth, Georgia, United States
- Iowa City, Iowa, United States
- Edina, Minnesota, United States
- Serra, Espírito Santo, Brazil
- Recife, Pernambuco, Brazil
- Natal, Rio Grande do Norte, Brazil
- Botucatu, São Paulo, Brazil
- Beijing, China
- Shanghai, China
- Prague, Czechia
- Munich, Bavaria, Germany
- Hanover, Germany
- Mainz, Germany
- Ranica, BG, Italy
- Brescia, BS, Italy
- Pavia, PV, Italy
- Kawasaki, Kanagawa, Japan
- Miyazaki, Japan
- Lodz, Poland
- Opole, Poland
- Seoul, Seoul, South Korea
- Seoul, South Korea
- Pamplona, Navarre, Spain
- Valencia, Valencia, Spain
- Barcelona, Spain
- Seville, Spain
- Kaohsiung City, Taiwan
- Taipei, Taiwan