ACTIVE_NOT_RECRUITING

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

Conditions

Primary Membranous Nephropathy BGB-3111 Zanubrutinib BTKi

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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:2027-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_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 Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

Study Director

STUDY_DIRECTOR

BeOne Medicines

Study Locations (Sites)

Amicis Research Center

Northridge, California, 91324-3528

United States

Stanford University

Palo Alto, California, 94304

United States

Intermed Consultants

Minneapolis, Minnesota, 55435-2130

United States

Kidney Specialist of Southern Nevada (Ksosn)

Las Vegas, Nevada, 89106-4852

United States

Carolina Nephrology

Spartanburg, South Carolina, 29306-3927

United States

Collaborators and Investigators

Sponsor: BeOne Medicines

Study Director, STUDY_DIRECTOR, BeOne Medicines

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 Date2027-10

Study Record Updates

Study Start Date2023-04-17

Study Completion Date2027-10

Terms related to this study

Keywords Provided by Researchers

BGB-3111
Zanubrutinib
BTKi

Additional Relevant MeSH Terms

Primary Membranous Nephropathy