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A Study to Evaluate the Safety and Efficacy of Zanubrutinib in Participants With Primary Membranous Nephropathy

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 who are on optimal supportive care.

Stanford is currently accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • drug: Zanubrutinib
  • drug: Tacrolimus
  • drug: Zanubrutinib

Eligibility


Inclusion Criteria:

   - Biopsy-confirmed primary membranous nephropathy 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 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

   - 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: Additional criteria may apply.

Ages Eligible for Study

18 Years - 75 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Brittany Yeung
650-498-3116
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