Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

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

Keywords

Primary Membranous Nephropathy, BGB-3111, Zanubrutinib, BTKi, Kidney Diseases, Membranous Glomerulonephritis, Tacrolimus

Eligibility

You can join if…

Open to people ages 18-75

  • 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)

You CAN'T join if...

  • 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/1.73m2 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.

Locations

  • University of California At San Francisco not yet accepting patients
    San Francisco California 94143 United States
  • Stanford University accepting new patients
    Palo Alto California 94304 United States
  • Amicis Research Center accepting new patients
    Northridge California 91324 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
BeiGene
ID
NCT05707377
Phase
Phase 2/3 research study
Study Type
Interventional
Participants
Expecting 282 study participants
Last Updated