A Study to Examine the Efficacy and Safety of Zanubrutinib Given to Adults With Primary Membranous Nephropathy
ALMOND
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
3 other identifiers
interventional
178
9 countries
48
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2023
Typical duration for phase_2
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2023
CompletedFirst Posted
Study publicly available on registry
January 31, 2023
CompletedStudy Start
First participant enrolled
April 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
March 5, 2026
March 1, 2026
4.5 years
January 23, 2023
March 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Part 1: Change from Baseline in Urine Protein Creatinine Ratio (UPCR)
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)
Week 104
Secondary Outcomes (17)
Part 1: Number of participants with Treatment Failure
Week 24
Part 1: Number of Participants with Immunological Response
Week 24
Part 1: Number of Participants with Complete Remission
Week 24, Week 52, Week 76, and Week 104
Part 1: Number of Participants with Overall Remission
Week 24, Week 52, Week 76, and Week 104
Part 1: Number of Participants with Relapse
Week 104
- +12 more secondary outcomes
Study Arms (4)
Part 1: Zanubrutinib High Dose
EXPERIMENTALParticipants will receive zanubrutinib twice daily.
Part 2: Zanubrutinib High Dose
EXPERIMENTALParticipants will receive zanubrutinib twice daily.
Part 2: Zanubrutinib Low Dose
EXPERIMENTALParticipants will receive zanubrutinib once daily.
Part 2: Tacrolimus
ACTIVE COMPARATORParticipants will receive tacrolimus capsules twice daily for 64 weeks.
Interventions
Zanubrutinib capsules administered orally.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeOne Medicineslead
Study Sites (48)
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
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45267-2827, United States
Carolina Nephrology
Spartanburg, South Carolina, 29306-3927, United States
Instituto Pro Renal Brasil
Curitiba, 80420-011, Brazil
Hcfmusp Hospital Das Clinicas Da Faculdade de Medicina Da Universidade de Sao Paulo
São Paulo, 05403-000, Brazil
Ott Healthcare, Inc (Corporate Medical Centre)
Scarborough Village, Ontario, M1H 3G4, Canada
Beijing An Zhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
Guangdong Provincial Peoples Hospital
Guangzhou, Guangdong, 510080, China
The First Affiliated Hospital, Sun Yat Sen University
Guangzhou, Guangdong, 510080, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
Guizhou Provincial Peoples Hospital
Guiyang, Guizhou, 550002, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 50000, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001, China
Nanyang Central Hospital
Nanyang, Henan, 473000, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060, China
The First Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia, 14017, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
Wuxi Peoples Hospital
Wuxi, Jiangsu, 214023, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004, China
Shandong Provincial Hospital
Jinan, Shandong, 250021, China
The Affiliated Hospital of Qingdao University Branch South
Qingdao, Shandong, 266000, China
Weifang Peoples Hospital
Weifang, Shandong, 261000, China
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080, China
Shanxi Provincial Peoples Hospital
Taiyuan, Shanxi, 030012, China
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, Sichuan, 610071, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
Zhejiang Provincial Peoples Hospital
Hangzhou, Zhejiang, 310014, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315010, China
Fakultni Nemocnice Olomouc
Olomouc, 77900, Czechia
Vseobecna Fakultni Nemocnice V Praze
Prague, 10000, Czechia
Istscientifico Di Pavia, Fondazione Smaugeri, Irccs, Clinica Del Lavoro E Della Riabilitazione
Pavia, 27100, Italy
Medical Company Llc
Grozny, Chechenskaya Respublika, 364029, Russia
Erciyes University Medical Faculty
Erciyes, 38030, Turkey (Türkiye)
Kocaeli University Research and Application Hospital Department of Nephrology
Kocaeli, 41380, Turkey (Türkiye)
Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN, United Kingdom
Royal Derby Hospital
Derby, DE22 3NE, United Kingdom
Related Publications (1)
Ahmad SB, Jefferson JA. Targeting B Cells and Plasma Cells in Glomerular Disease. J Am Soc Nephrol. 2025 Jun 4;36(9):1844-1857. doi: 10.1681/ASN.0000000772.
PMID: 40465397DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
BeOne Medicines
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2023
First Posted
January 31, 2023
Study Start
April 17, 2023
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
October 1, 2027
Last Updated
March 5, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See plan description
- Access Criteria
- See plan description
BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.