A Study to Evaluate the Safety and Efficacy of Zanubrutinib in Participants With Primary Membranous Nephropathy
Trial ID or NCT#
NCT05707377
Status
RECRUITING
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
Eligibility Criteria
Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Brittany Yeung
650-498-3116
View on ClinicalTrials.gov
