A Study to Evaluate the Safety and Efficacy of Zanubrutinib in Participants With Primary Membranous Nephropathy

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BeiGene

Status and phase

Enrolling
Phase 3
Phase 2

Conditions

Primary Membranous Nephropathy

Treatments

Drug: Tacrolimus
Drug: Zanubrutinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT05707377
CTR20230546 (Registry Identifier)
BGB-3111-309
2022-501147-32-00 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

282 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

282 participants in 3 patient groups

Part 1 and Part 2: Zanubrutinib High dose
Experimental group
Description:
Participants will receive Zanubrutinib twice daily
Treatment:
Drug: Zanubrutinib
Drug: Zanubrutinib
Part 2: Zanubrutinib Low Dose
Experimental group
Description:
Participants will receive Zanubrutinib once daily
Treatment:
Drug: Zanubrutinib
Drug: Zanubrutinib
Tacrolimus
Active Comparator group
Description:
Participants will receive tacrolimus capsules for 64 weeks
Treatment:
Drug: Tacrolimus

Trial contacts and locations

50

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Central trial contact

Study Director

Data sourced from clinicaltrials.gov

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