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

Официальное название

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.

Обзор

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

Подробное описание

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 year of treatment (Group A) or at the end of the second year of treatment (Group B).

The total study duration for each participant may be up to 125 weeks, including the maximum screening period (8 weeks), the treatment period (104 weeks), and the safety follow up period (13 weeks).

Вмешательства

• Биопрепарат zigakibart
  zigakibart 600 mg sc injections every second week for 104 weeks (2 years)

Первичные конечные точки

• Change in mesangial IgA deposition [Срок оценки: Baseline to Week 53 or 105]

Вторичные конечные точки (11)

• Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: Day 1 to Week 118]
• Change in MEST-C score [Срок оценки: Baseline to Week 53 or 105]
• Change in CD68+ cells in glomeruli and tubulo-interstitial compartment [Срок оценки: Baseline to Week 53 or 105]
• Change in complement component C3c [Срок оценки: Baseline to Week 53 or 105]
• Change in UPCR [Срок оценки: Baseline to Week 53 and 105]
• Change in eGFR [Срок оценки: Baseline to Week 53 and 105]
• Change in albuminuria [Срок оценки: Baseline to Week 53 and 105]
• Change in hematuria [Срок оценки: Baseline to Week 53 and 105]
• Change in serum IgA, IgM and IgG [Срок оценки: Baseline to Week 13, 29, 53, 79 and 105]
• Serum zigakibart concentrations [Срок оценки: Baseline, Week 13, 29, 66, 79 and 105]
• Circulating anti-zigakibart antibodies [Срок оценки: Baseline, Week 13, 29, 66, 79 and 105]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 4 центра

• Colorado Kidney Care Nephrology — Denver
• American Clinical Trials — Acworth
• Univ Of Iowa Hospitals And Clinics — Iowa City
• Inter Med Consultants — Edina

Испания · 4 центра

• Novartis Investigative Site — Pamplona
• Novartis Investigative Site — Valencia
• Novartis Investigative Site — Barcelona
• Novartis Investigative Site — Seville

Германия · 3 центра

• Novartis Investigative Site — Munich
• Novartis Investigative Site — Hanover
• Novartis Investigative Site — Mainz

Италия · 3 центра

• Novartis Investigative Site — Ranica
• Novartis Investigative Site — Brescia
• Novartis Investigative Site — Pavia

Бразилия · 2 центра

• Novartis Investigative Site — Serra
• Novartis Investigative Site — Botucatu

Китай · 2 центра

• Novartis Investigative Site — Пекин
• Novartis Investigative Site — Шанхай

Япония · 2 центра

• Novartis Investigative Site — Kawasaki
• Novartis Investigative Site — Miyazaki

Польша · 2 центра

• Novartis Investigative Site — Lodz
• Novartis Investigative Site — Opole

South Korea · 2 центра

• Novartis Investigative Site — Seoul
• Novartis Investigative Site — Seoul

Тайвань · 2 центра

• Novartis Investigative Site — Kaohsiung City
• Novartis Investigative Site — Taipei

Идентификаторы

NCT: NCT07146906 · CFUB523A12201 · 2024-519699-24 · U1111-1323-5075

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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