A Phase III, Randomized, Open-Label Active Comparator-Controlled Multicenter Study to Evaluate Efficacy and Safety of Obinutuzumab in Patients with Primary Membranous Nephropathy - WA41937

F. Hoffmann-La Roche AG0 个研究点目标入组 140 人开始时间: 2024年1月29日最近更新: 2024年7月22日

适应症

试验速览

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•Ability to comply with the study protocol, in the investigator's judgment, Diagnosis of pMN according to renal biopsy prior to or during screening, Screening urinary protein-to-creatinine ratio (UPCR) >= 5 g/g from 24-hour urine collection after best supportive care for >= 3 months prior to screening or screening UPCR >= 4 g/g after best supportive care for >= 6 months prior to screening, eGFR >= 40 mL/min/1.73m2 or qualified endogenous creatinine clearance >= 40 mL/min/1.73m2 based on 24-hour urine collection during screening, Patients who previously responded to calcineurin inhibitor (CNIs), rituximab, or alkylating agents with either a CR or partial remission and subsequently relapsed are eligible but require discontinuation of CNIs or alkylating agents for >= 6 months and rituximab for >= 9 months prior to screening, For patients enrolled in the extended China enrollment phase at China’s sites: current resident of mainland China and of Chinese ancestry

•Uncontrolled blood pressure, in the opinion of the investigator, during 3 months prior to screening, Evidence of >= 50% reduction in proteinuria during the previous 6 months prior to randomization, Receipt of renal replacement therapy, Type 1 or 2 diabetes mellitus, Receipt of previous therapies as follows: - Treatment with MMF or oral, intramuscular, or intravenous corticosteroids within 1 month prior to or during screening - Any B-cell depleting therapy such as rituximab, ocrelizumab, or ofatumumab within 9 months prior to or during screening - Treatment with cyclophosphamide or CNI within 6 months prior to or during screening - Treatment with any biologic therapy such as belimumab, ustekinumab, or anifrolumab within 6 months prior to or during screening - Treatment with an inhibitor of Janus-associated kinase, Bruton’s tyrosine kinase, or tyrosine kinase 2, including but not limited to tofacitinib, baricitinib, upadacitinib, filgotinib, ibrutinib, or fenebrutinib within 3 months prior to or during screening - Treatment with any investigational agent within 28 days of screening or 5 drug-elimination half-lives of the investigational drug, whichever is longer - Receipt of a live vaccine within 28 days prior to screening or during screening, Patients with a secondary cause of MN (e.g., hepatitis B, SLE, medications, malignancies)

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