A Study to Examine the Efficacy and Safety of Zanubrutinib Given to Adults With Primary Membranous Nephropathy
Trial ID or NCT#
Status
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 (PMN) 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
- * 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)
- * 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.
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Brittany Yeung
650-498-3116
View on ClinicalTrials.gov