Home › Trials › NCT05707377

Evaluating Zanubrutinib for Adults with Primary Membranous Nephropathy

A Phase 2/3, Multicenter, Randomized, Active-Controlled, Open-label Study to Evaluate the Efficacy and Safety of Zanubrutinib in Patients With Primary Membranous Nephropathy

PHASE2; PHASE3 · BeiGene · NCT05707377

This study is testing if zanubrutinib can help adults with primary membranous nephropathy reduce protein in their urine and achieve better remission rates compared to tacrolimus.

Quick facts

PhasePHASE2; PHASE3
Study typeInterventional
Enrollment282 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorBeiGene (industry)
Drugs / interventionszanubrutinib
Locations71 sites (Northridge, California and 70 other locations)
Trial IDNCT05707377 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with biopsy-confirmed primary membranous nephropathy and specific proteinuria levels who have been on optimal supportive care.

Not a fit: Patients with secondary causes of membranous nephropathy or severe renal disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients with primary membranous nephropathy by reducing proteinuria and increasing remission rates.

How similar studies have performed: Other studies have shown promise with similar BTK inhibitors, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Northridge, California and 70 other locations

+21 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Primary Membranous Nephropathy, BGB-3111, Zanubrutinib, BTKi

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.