A Study to Examine the Efficacy and Safety of Zanubrutinib Given to Adults With Primary Membranous Nephropathy
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
On this site
📄 Brukinsa (zanubrutinib) drug profile →More BeOne Medicines trials in the UK
Other trials for the same condition
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