EUCTR2020-003233-38-IT进行中（未招募）1 期
A PHASE III, RANDOMIZED, OPEN-LABEL ACTIVE COMPARATOR-CONTROLLED MULTICENTER STUDY TO EVALUATE EFFICACY AND SAFETY OF OBINUTUZUMAB IN PATIENTS WITH PRIMARY MEMBRANOUS NEPHROPATHY - A Study to Evaluate Efficacy and Safety of Obinutuzumab in Patients with Primary Membranous Nephropa
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age 18-75 years
- •Diagnosis of pMN according to renal biopsy prior to or during screening
- •Urinary protein-to-creatinine ratio (UPCR) >= 5 g from 24-hour urine collection despite best supportive care for >= 3 months prior to screening or UPCR >= 4 g despite best supportive care >= 6 months prior to screening
- •Systolic blood pressure <= 140 mmHg and diastolic blood pressure <= 90 mmHg at screening
- •eGFR >= 40 mL/min/1.73m2 or qualified endogenous creatinine clearance >= 40 mL/min 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 women of childbearing potential: agreement to remain abstinent or use adequate contraception during the treatment period and for 18 months after the final dose of obinutuzumab and for 28 days after the final dose of tacrolimus
- •For men receiving tacrolimus: agreement to remain abstinent or use a condom, as defined below: With a female partner of childbearing potential or pregnant female partner, men must remain abstinent or use a condom during the treatment period and for 28 days after the final dose of tacrolimus to avoid exposing the embryo
- •For patients enrolled in the extended China enrollment phase at National Medical Products Administration-recognized sites: current resident of mainland China and of Chinese ancestry
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 119
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 21
排除标准
- •Patients with a secondary cause of MN
- •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 screening
- •Receipt of renal replacement therapy
- •Type 1 or 2 diabetes mellitus
- •Pregnant or breastfeeding, or intending to become pregnant during the study or within 18 months after the final dose of obinutuzumab or 28 days after the final dose of tacrolimus
- •History of resistance (no response) to CNIs or B-cell depleting antibodies
- •Receipt of previous therapies as follows:
- •oTreatment with MMF or oral, intramuscular, or intravenous corticosteroids within 1 month prior to screening
- •oAny B-cell depleting therapy such as rituximab, ocrelizumab, or ofatumumab within 9 months prior to screening
- •oTreatment with cyclophosphamide or CNI within 6 months prior to screening
- •oTreatment with any biologic therapy such as belimumab, ustekinumab, or anifrolumab within 6 months prior to screening
- •oTreatment 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 screening
- •oTreatment with any investigational agent within 28 days of screening or 5 drug-elimination half-lives of the investigational drug, whichever is longer
- •oReceipt of a live vaccine within 28 days prior to screening or during screening
- •Thrombocytopenia, anemia, and/or coagulopathy with high risk for clinically significant bleeding or organ dysfunction or requiring plasmapheresis, intravenous immunoglobulin, or acute blood product transfusions
- •Significant or uncontrolled medical disease which, in the investigator’s opinion, would preclude patient participation
- •Known HIV infection
- •Tuberculosis infection
- •Known active infection of any kind, excluding fungal infection of the nail beds
- •Any major episode of infection requiring hospitalization or treatment either with IV anti-infective treatments during the 2 months prior to or during screening or with oral anti-infective treatments during the 2 weeks prior to or during screening
- •History of serious recurrent or chronic infection, progressive multifocal leukoencephalopathy, cancer, carcinoma in situ, except non-melanomatous carcinomas of the skin that have been treated or excised and have resolved
- •Major surgery requiring hospitalization within the 4 weeks prior to screening
- •Current active alcohol or drug abuse or history of alcohol or drug abuse within 12 months prior to screening
- •Intolerance or contraindication to study therapies, including:
- •oEvidence of intolerance or toxicity associated with tacrolimus prior to screening
- •oHistory of severe allergic or anaphylactic reactions to monoclonal antibodies or known hypersensitivity to any component of the obinutuzumab infusion
- •oIntolerance or contraindication to oral or IV corticosteroids and premedications
- •oIntolerance or hypersensitivity to tacrolimus and its excipients
- •oLack of peripheral venous access
- •Laboratory parameters
- •oaspartate aminotransferase or alanine transaminase > 2.5 ×the upper limit of normal (ULN)
- •oAmylase or lipase > 2 × ULN
- •oNeutrophils < 1.5 × 103/micro L
- •oCD19+ B cells < 5/micro L
- •oPositive for hepatitis B surface antigen (HBsAg) at screening
- •oPositive hepatitis C virus antibody at screening
- •oHemoglobin < 9 g/dL
- •oPlatelet count < 75,000/micro L
- •oPositive serum human chorionic gon
研究者
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