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A Study to Evaluate the Safety and Efficacy of Zanubrutinib in Participants With Primary Membranous Nephropathy
Recruiting
I'm InterestedTrial ID: NCT05707377
Purpose
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.
Official Title
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
Stanford Investigator(s)
Richard Lafayette
Professor of Medicine (Nephrology)
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.
Intervention(s):
drug: Zanubrutinib
drug: Tacrolimus
drug: Zanubrutinib
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Brittany Yeung
650-498-3116