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

Description

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.

Conditions

Primary Membranous Nephropathy

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Primary Membranous Nephropathy
Intervention / Treatment

-

Contacts and Locations

Montgomery

Renal Associates of Alabama, Llc, Montgomery, Alabama, United States, 36117

Northridge

Amicis Research Center, Northridge, California, United States, 91324

Palo Alto

Stanford University, Palo Alto, California, United States, 94304

San Francisco

University of California At San Francisco, San Francisco, California, United States, 94143

Aurora

University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States, 80045

Columbus

Renal Associates, Llc, Columbus, Georgia, United States, 31904

Chicago

Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States, 60611

Evanston

Northshore University Healthsystem, Evanston, Illinois, United States, 60201

Edina

Intermed Consultants, Edina, Minnesota, United States, 55435

Las Vegas

Kidney Specialist of Southern Nevada (Ksosn), Las Vegas, Nevada, United States, 89106

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

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

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

BeiGene,

Study Director, STUDY_DIRECTOR, BeiGene

Study Record Dates

2028-04