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Active, not recruiting Phase 2/3

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

NCT05707377 · tracked via the Priya Life Science UK tracker
Phase
Phase 2/3
Started
2023-04-17
Last updated
2026-09-11

Condition(s) studied

Primary Membranous Nephropathy

Investigational drug(s) / intervention(s)

Zanubrutinib →Tacrolimus →

Zanubrutinib: Zanubrutinib capsules administered orally.

Tacrolimus: Tacrolimus capsules administered orally.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Part 1: Change from Baseline in Urine Protein Creatinine Ratio (UPCR) — Baseline and Week 24
  • Part 2: Number of Participants Achieving Complete Remission — Week 104
    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)

Trial sites (45)

FacilityCityRegionStatus
Amicis Research Center Granada Hills California
Stanford University Palo Alto California
Intermed Consultants Minneapolis Minnesota
Kidney Specialist of Southern Nevada (Ksosn) Las Vegas Nevada
Instituto Pro Renal Brasil Curitiba Brazil
Ott Healthcare, Inc (Corporate Medical Centre) Scarborough Village Ontario
Beijing An Zhen Hospital, Capital Medical University Beijing Beijing Municipality
Peking University First Hospital Beijing Beijing Municipality
Fujian Medical University Union Hospital Fuzhou Fujian
The First Affiliated Hospital of Fujian Medical University Fuzhou Fujian
The First Affiliated Hospital of Xiamen University Xiamen Fujian
Guangdong Provincial Peoples Hospital Guangzhou Guangdong
The First Affiliated Hospital, Sun Yat Sen University Guangzhou Guangdong
Peking University Shenzhen Hospital Shenzhen Guangdong
The First Affiliated Hospital of Guangxi Medical University Nanning Guangxi
Guizhou Provincial Peoples Hospital Guiyang Guizhou
The First Hospital of Hebei Medical University Shijiazhuang Hebei
The Second Affiliated Hospital of Harbin Medical University Harbin Heilongjiang
Nanyang Central Hospital Nanyang Henan
The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology Wuhan Hubei
Renmin Hospital of Wuhan University Wuhan Hubei
The First Affiliated Hospital of Baotou Medical College Baotou Inner Mongolia
Jiangsu Province Hospital Nanjing Jiangsu
Wuxi Peoples Hospital Wuxi Jiangsu
General Hospital of Ningxia Medical University Yinchuan Ningxia
Shandong Provincial Hospital Jinan Shandong
The Affiliated Hospital of Qingdao University Branch South Qingdao Shandong
Weifang Peoples Hospital Weifang Shandong
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine Shanghai Shanghai Municipality
Shanghai General Hospital Shanghai Shanghai Municipality
Shanxi Provincial Peoples Hospital Taiyuan Shanxi
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital Chengdu Sichuan
The First Affiliated Hospital of Xinjiang Medical University Ürümqi Xinjiang
The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang
Zhejiang Provincial Peoples Hospital Hangzhou Zhejiang
The First Affiliated Hospital of Ningbo University Ningbo Zhejiang
Fakultni Nemocnice Olomouc Olomouc Czechia
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Istscientifico Di Pavia, Fondazione Smaugeri, Irccs, Clinica Del Lavoro E Della Riabilitazione Pavia Italy

+ 5 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05707377 on ClinicalTrials.gov ↗ ← All trials in the UK