RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2023-04-17
Study Completion:2028-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05707377

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Biopsy-confirmed PMN within 5 years before the initial screening (ie, the day the informed consent is signed)
  2. * UPCR (based on 24-hour urine collection) \> 3.5 at initial screening and at confirmation assessment
  3. * 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)
  4. * Anti-PLA2R antibody \> 50 RU/mL at confirmation assessment (Part 1 only)
  1. * Participants with a secondary cause of membranous nephropathy
  2. * Type 1 or 2 diabetes mellitus with hemoglobin A1c (HbA1c) ≥ 7% at screening
  3. * 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)
  4. * 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
  5. * Patients at risk for tuberculosis at screening
  6. * Known infection with serologic status reflecting active or chronic hepatitis B virus infection, or presence of hepatitis C virus antibody
  7. * Severe hepatic insufficiency (Child-Pugh C)
  8. * Clinically significant cardio-cerebrovascular diseases

Contacts and Locations

Study Contact

Study Director
CONTACT
1-877-828-5568
clinicaltrials@beigene.com

Principal Investigator

Study Director
STUDY_DIRECTOR
BeiGene

Study Locations (Sites)

Renal Associates of Alabama, Llc
Montgomery, Alabama, 36117
United States
Amicis Research Center
Northridge, California, 91324
United States
Stanford University
Palo Alto, California, 94304
United States
University of California At San Francisco
San Francisco, California, 94143
United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
United States
Renal Associates, Llc
Columbus, Georgia, 31904
United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
United States
Northshore University Healthsystem
Evanston, Illinois, 60201
United States
Intermed Consultants
Edina, Minnesota, 55435
United States
Kidney Specialist of Southern Nevada (Ksosn)
Las Vegas, Nevada, 89106
United States
Columbia University Irving Medical Center
New York, New York, 10032
United States
Cardinal Clinical Research, Llc
Rutherfordton, North Carolina, 28139
United States
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45267
United States
Carolina Nephrology
Spartanburg, South Carolina, 29306
United States
Prolato Clinical Research Center
Houston, Texas, 77054
United States
Kidney Specialists of North Houston
Shenandoah, Texas, 77384
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: BeiGene

  • Study Director, STUDY_DIRECTOR, BeiGene

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-17
Study Completion Date2028-04

Study Record Updates

Study Start Date2023-04-17
Study Completion Date2028-04

Terms related to this study

Keywords Provided by Researchers

  • BGB-3111
  • Zanubrutinib
  • BTKi

Additional Relevant MeSH Terms

  • Primary Membranous Nephropathy