A Study to Examine the Efficacy and Safety of Zanubrutinib Given to Adults With Primary Membranous Nephropathy

Running, not enrolling · Phase 2/Phase 3

Conditions studied: Primary Membranous Nephropathy

In brief

The primary objectives of this study are: In Part 1 to evaluate the efficacy of zanubrutinib as measured by proteinuria reduction, and in Part 2 to evaluate the efficacy of zanubrutinib compared with tacrolimus as measured by complete remission rate, in participants with primary membranous nephropathy (PMN) who are on optimal supportive care.

Key facts

Study ID

NCT05707377

Run by

BeOne Medicines

People needed

178

Starts

2023-04-17

Expected to finish

2027-10-01

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Biopsy-confirmed PMN within 5 years before the initial screening (ie, the day the informed consent is signed)
• UPCR (based on 24-hour urine collection) > 3.5 at initial screening and at 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 (blood pressure < 130/80 mmHg, measured on ≥ 2 occasions [not on the same day] within 4 weeks before the assignment of study treatment)
• Anti-PLA2R antibody > 50 RU/mL at confirmation assessment (Part 1 only)

You may not qualify if…

• Participants with a secondary cause of membranous nephropathy
• Type 1 or 2 diabetes mellitus with hemoglobin A1c (HbA1c) ≥ 7% at screening
• Severe renal disease as determined by rapid decline in eGFR (defined as > 15 mL/min/1.73m\^2 within 24 weeks prior to randomization, not otherwise explained)
• 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
• Patients at risk for 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: Other protocol defined Inclusion/Exclusion criteria may apply.

Where it is running

• Amicis Research Center — Granada Hills, California, United States
• Stanford University — Palo Alto, California, United States
• Intermed Consultants — Minneapolis, Minnesota, United States
• Kidney Specialist of Southern Nevada (Ksosn) — Las Vegas, Nevada, United States
• University of Cincinnati College of Medicine — Cincinnati, Ohio, United States
• Carolina Nephrology — Spartanburg, South Carolina, United States
• Instituto Pro Renal Brasil — Curitiba, Brazil
• Ott Healthcare, Inc (Corporate Medical Centre) — Scarborough Village, Ontario, Canada
• Beijing An Zhen Hospital, Capital Medical University — Beijing, Beijing Municipality, China
• Peking University First Hospital — Beijing, Beijing Municipality, China
• Fujian Medical University Union Hospital — Fuzhou, Fujian, China
• The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China
• The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China
• Guangdong Provincial Peoples Hospital — Guangzhou, Guangdong, China
• The First Affiliated Hospital, Sun Yat Sen University — Guangzhou, Guangdong, China
• Peking University Shenzhen Hospital — Shenzhen, Guangdong, China
• The First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China
• Guizhou Provincial Peoples Hospital — Guiyang, Guizhou, China
• The First Hospital of Hebei Medical University — Shijiazhuang, Hebei, China
• The Second Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China
• Nanyang Central Hospital — Nanyang, Henan, China
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China
• Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology — Wuhan, Hubei, China
• Renmin Hospital of Wuhan University — Wuhan, Hubei, China
• The First Affiliated Hospital of Baotou Medical College — Baotou, Inner Mongolia, China

Full record on ClinicalTrials.gov

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