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

Launched by BEIGENE · Jan 23, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called zanubrutinib to see how safe and effective it is for treating a kidney condition known as primary membranous nephropathy. The trial is divided into two parts: in the first part, researchers will look at how well zanubrutinib reduces protein in the urine, and in the second part, they will compare its effectiveness to another medication called tacrolimus by measuring the rate of complete remission from the disease. The trial is currently recruiting participants aged between 65 and 74 years, as well as younger adults up to 39 years old, who have been diagnosed with primary membranous nephropathy.

To be eligible for this trial, participants need to have been diagnosed with primary membranous nephropathy within the past five years and have specific urine test results showing high protein levels. They should also have been on certain blood pressure medications for at least 24 weeks before joining the study. However, people with other serious health issues, such as diabetes or certain infections, may not be eligible. Participants in the trial will receive either zanubrutinib or tacrolimus and will be closely monitored by the study team. This trial aims to find better treatment options for individuals with this kidney condition.

Gender

ALL

Eligibility criteria

• Inclusion 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)
• Exclusion Criteria:
• • 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.