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New drug zanubrutinib takes on kidney disease in major trial

NCT ID NCT05707377

Disease control Sponsor: BeOne Medicines Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 3 times

Summary

This study tests whether the drug zanubrutinib can help people with primary membranous nephropathy, a kidney disease that causes protein leakage. About 178 participants will receive either zanubrutinib or the standard drug tacrolimus. The goal is to see if zanubrutinib reduces protein in urine and leads to complete remission of the disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
zanubrutinib
What this could lead to
If successful, zanubrutinib could offer a new treatment option for people with this kidney disease, potentially reducing protein leakage and preserving kidney function.
What could go wrong
This is a mid-stage trial with 178 participants, so results are not yet proven. Zanubrutinib may not work better than the current drug, and side effects like infection or bleeding are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

178 people

The number who actually took part.

Started

Apr 2023

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

idiopathic membranous glomerulonephritis membranous glomerulonephritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Primary membranous nephropathy

Contacts and locations

Locations

  • Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZN, United Kingdom

  • Amicis Research Center

    Granada Hills, California, 91344, United States

  • Beijing An Zhen Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100029, China

  • Erciyes University Medical Faculty

    Erciyes, 38030, Turkey (Türkiye)

  • Fakultni Nemocnice Olomouc

    Olomouc, 77900, Czechia

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001, China

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750004, China

  • Guangdong Provincial Peoples Hospital

    Guangzhou, Guangdong, 510080, China

  • Guizhou Provincial Peoples Hospital

    Guiyang, Guizhou, 550002, China

  • Instituto Pro Renal Brasil

    Curitiba, 80420-011, Brazil

  • Intermed Consultants

    Minneapolis, Minnesota, 55435-2130, United States

  • Istscientifico Di Pavia, Fondazione Smaugeri, Irccs, Clinica Del Lavoro E Della Riabilitazione

    Pavia, 27100, Italy

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029, China

  • Kidney Specialist of Southern Nevada (Ksosn)

    Las Vegas, Nevada, 89106-4852, United States

  • Kocaeli University Research and Application Hospital Department of Nephrology

    Kocaeli, 41380, Turkey (Türkiye)

  • Medical Company Llc

    Grozny, Chechenskaya Respublika, 364029, Russia

  • Nanyang Central Hospital

    Nanyang, Henan, 473000, China

  • Ott Healthcare, Inc (Corporate Medical Centre)

    Scarborough Village, Ontario, M1H 3G4, Canada

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034, China

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, 518036, China

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430060, China

  • Royal Derby Hospital

    Derby, DE22 3NE, United Kingdom

  • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200025, China

  • Shandong Provincial Hospital

    Jinan, Shandong, 250000, 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

  • Stanford University

    Palo Alto, California, 94304, United States

  • The Affiliated Hospital of Qingdao University Branch South

    Qingdao, Shandong, 266000, China

  • The First Affiliated Hospital of Baotou Medical College

    Baotou, Inner Mongolia, 14017, China

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350005, China

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021, China

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang, 315010, China

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003, China

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830054, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052, China

  • The First Affiliated Hospital, Sun Yat Sen University

    Guangzhou, Guangdong, 510080, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003, China

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 50000, China

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001, China

  • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430030, China

  • Vseobecna Fakultni Nemocnice V Praze

    Prague, 10000, Czechia

  • Weifang Peoples Hospital

    Weifang, Shandong, 261000, China

  • Wuxi Peoples Hospital

    Wuxi, Jiangsu, 214023, China

  • Zhejiang Provincial Peoples Hospital

    Hangzhou, Zhejiang, 310014, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.