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

Phase 3Active Not RecruitingNCT05707377

BeOne Medicines178 enrolled

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.

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

178

Conditions

Primary Membranous Nephropathy

Interventions

ZanubrutinibDRUG

Zanubrutinib capsules administered orally.

TacrolimusDRUG

Tacrolimus capsules administered orally.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion 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) Exclusion Criteria: * 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 Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations (51)

Outcomes

Primary Outcomes

Part 1: Change from Baseline in Urine Protein Creatinine Ratio (UPCR)

Time frame: Baseline and Week 24

Part 2: Number of Participants Achieving Complete Remission

Complete remission is defined as: UPCR (based on 24-hour urine collection) ≤ 0.3, AND a stable estimated glomerular filtration rate (eGFR) (remains unchanged or decreases by \< 15% compared with the baseline)

Time frame: Week 104

Secondary Outcomes

Part 1: Number of participants with Treatment Failure

Time frame: Week 24

Part 1: Number of Participants with Immunological Response

Immunological response is defined as anti- phospholipase A2 receptor (PLA2R) antibody level reduced from baseline to less than 14 relative units (RU)/ml.

Time frame: Week 24

Part 1: Number of Participants with Complete Remission

A complete remission is defined as: UPCR (based on 24-hour urine collection) ≤ 0.3, AND a stable eGFR (remains unchanged or decreases by \< 15% compared with the baseline)

Time frame: Week 24, Week 52, Week 76, and Week 104

Part 1: Number of Participants with Overall Remission

Participants with overall remission are those achieving either complete remission or partial remission

Time frame: Week 24, Week 52, Week 76, and Week 104

Part 1: Number of Participants with Relapse

A relapse is defined as reappearance of UPCR (based on 24-hour urine collection) \> 3.5 after complete or partial remission

Time frame: Week 104

Data from ClinicalTrials.gov

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Amicis Research Center

Northridge, California, United States

Stanford University

Palo Alto, California, United States

Intermed Consultants

Minneapolis, Minnesota, United States

Kidney Specialist of Southern Nevada (Ksosn)

Las Vegas, Nevada, United States

University of Cincinnati College of Medicine

Cincinnati, Ohio, United States

Carolina Nephrology

Spartanburg, South Carolina, United States

Instituto Pro Renal Brasil

Curitiba, Brazil

Hcfmusp Hospital Das Clinicas Da Faculdade de Medicina Da Universidade de Sao Paulo

São Paulo, Brazil

Ott Healthcare, Inc (Corporate Medical Centre)

Scarborough Village, Ontario, Canada

Beijing An Zhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

...and 41 more locations

Part 1: Number Of Participants with Treatment-Emergent Adverse Events (TEAEs)

Time frame: From the first dose of study drug and up to 30 days after study drug discontinuation; up to approximately 68 weeks

Part 2: Number of Participants with Overall Remission

Participants with overall remission are those achieving either complete remission or partial remission

Time frame: Week 24, Week 52, Week 76, and Week 104

Part 2: Number of Participants with Complete Remission

A complete remission is defined as: UPCR (based on 24-hour urine collection) ≤ 0.3, AND a stable eGFR (remains unchanged or decreases by \< 15% compared with the baseline)

Time frame: Week 24, Week 52, and Week 76

Part 2: Number of participants with Treatment Failure

Time frame: Week 24, Week 52, Week 76, and Week 104

Part 2: Time to First Complete Remission

Time to First Complete Remission is the time from the date of randomization to the date of the first complete remission