Evaluating Zanubrutinib for Adults with Primary Membranous Nephropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the efficacy and safety of zanubrutinib in adults diagnosed with primary membranous nephropathy (PMN). In the first part, the study will measure the reduction of proteinuria in participants receiving zanubrutinib. The second part will compare the effectiveness of zanubrutinib against tacrolimus in achieving complete remission rates, with all participants receiving optimal supportive care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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's running

• Amicis Research Center
  Northridge, California, United States Recruiting
• Stanford University
  Palo Alto, California, United States Recruiting
• Northwestern University Feinberg School of Medicine
  Chicago, Illinois, United States Recruiting
• Northshore University Healthsystem
  Evanston, Illinois, United States Recruiting
• Intermed Consultants
  Minneapolis, Minnesota, United States Recruiting
• Kidney Specialist of Southern Nevada (Ksosn)
  Las Vegas, Nevada, United States Recruiting

+21 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Study Director
• Email: clinicaltrials@beigene.com
• Phone: 1-877-828-5568

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.