A Study to Evaluate the Safety and Efficacy of Zanubrutinib in Participants With Primary Membranous Nephropathy
Primary Membranous Nephropathy
About this trial
This is an interventional treatment trial for Primary Membranous Nephropathy
Eligibility Criteria
Inclusion Criteria: Biopsy-confirmed primary membranous nephropathy UPCR (based on 24-hour urine collection) > 3.5 at initial screening and confirmation assessment Treatment with a maximally tolerated or allowed dose of an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin II receptor blocker (ARB) for ≥ 24 weeks before randomization (12 weeks before initiation of study drug for Part 1) and with adequate blood pressure control Anti-PLA2R antibody > 50 RU/mL at confirmation assessment (Part 1 only) Exclusion Criteria: Participants with a secondary cause of membranous nephropathy Type 1 or 2 diabetes mellitus with hemoglobin A1c (HbA1c) ≥ 7% at screening The eGFR < 40 mL/min/1.73 m2, or initiation of dialysis A known history of a primary immunodeficiency or an underlying condition such as human immunodeficiency virus (HIV) infection or splenectomy that predisposes the participant to infections Positive tuberculosis at screening Known infection with serologic status reflecting active or chronic hepatitis B virus infection, or presence of hepatitis C virus antibody Severe hepatic insufficiency (Child-Pugh C) Clinically significant cardio-cerebrovascular diseases Note: Additional criteria may apply.
Sites / Locations
- Stanford UniversityRecruiting
- Intermed ConsultantsRecruiting
- Kidney Specialist of Southern Nevada (Ksosn)Recruiting
- Carolina NephrologyRecruiting
- Prolato Clinical Research CenterRecruiting
- Beijing An Zhen Hospital of the Capital University of Medical SciencesRecruiting
- Peking University First HospitalRecruiting
- Peking University Peoples HospitalRecruiting
- The First Affiliated Hospital of Fujian Medical UniversityRecruiting
- Guangdong Provincial Peoples HospitalRecruiting
- The First Affiliated Hospital, Sun Yat Sen UniversityRecruiting
- Peking University Shenzhen HospitalRecruiting
- The First Affiliated Hospital of Guangxi Medical UniversityRecruiting
- Guizhou Provincial Peoples HospitalRecruiting
- The First Hospital of Hebei Medical UniversityRecruiting
- Nanyang Central HospitalRecruiting
- The First Affiliated Hospital of Zhengzhou UniversityRecruiting
- Renmin Hospital of Wuhan UniversityRecruiting
- Zhongda Hospital Southeast UniversityRecruiting
- Jiangsu Province HospitalRecruiting
- Wuxi Peoples HospitalRecruiting
- Affiliated Hospital of Jiangsu UniversityRecruiting
- Shengjing Hospital of China Medical UniversityRecruiting
- General Hospital of Ningxia Medical UniversityRecruiting
- Shandong Provincial HospitalRecruiting
- The Affiliated Hospital of Qingdao University Branch SouthRecruiting
- Rui Jin Hospital Shanghai Jiao Tong University School of MedicineRecruiting
- Shanghai General HospitalRecruiting
- Shanxi Provincial Peoples HospitalRecruiting
- Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples HospitalRecruiting
- The First Affiliated Hospital of Xinjiang Medical UniversityRecruiting
- The First Peoples Hospital of Yunnan ProvinceRecruiting
- The First Affiliated Hospital, Zhejiang University School of MedicineRecruiting
- Zhejiang Provincial Peoples HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
Part 1 and Part 2: Zanubrutinib High dose
Part 2: Zanubrutinib Low Dose
Tacrolimus
Participants will receive Zanubrutinib twice daily
Participants will receive Zanubrutinib once daily
Participants will receive tacrolimus capsules for 64 weeks