For Healthcare Professionals

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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. Biopsy-confirmed PMN within 5 years before the initial screening (ie, the day the informed consent is signed)
  2. UPCR (based on 24-hour urine collection) > 3.5 at initial screening and at confirmation assessment
  3. 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)
  4. Anti-PLA2R antibody > 50 RU/mL at confirmation assessment (Part 1 only)

EXCLUSION CRITERIA

Exclusion Criteria:


  1. Participants with a secondary cause of membranous nephropathy
  2. Type 1 or 2 diabetes mellitus with hemoglobin A1c (HbA1c) ≥ 7% at screening
  3. 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)
  4. 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
  5. Patients at risk for tuberculosis at screening
  6. Known infection with serologic status reflecting active or chronic hepatitis B virus infection, or presence of hepatitis C virus antibody
  7. Severe hepatic insufficiency (Child-Pugh C)
  8. Clinically significant cardio-cerebrovascular diseases

Note: Other protocol defined Inclusion/Exclusion criteria may apply.


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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 1-877-828-5568Email iconEmail Study Center

Study Details


Contition

Primary Membranous Nephropathy

Age

18 - 75

Phase

PHASE2/PHASE3

Participants Needed

282

Est. Completion Date

Apr 30, 2028

Treatment Type

INTERVENTIONAL


Sponsor

BeiGene

ClinicalTrials.gov NCT Identifier

NCT05707377

Study Number

BGB-3111-309

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