NCT04643470CompletedPhase 2
Zanubrutinib in Participants With Active Proliferative Lupus Nephritis
A Phase 2, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of Zanubrutinib in Patients With Active Proliferative Lupus Nephritis
Source: ClinicalTrials.gov · Last updated 29 Nov 2024
Brief summary (registry, in English)
The primary objective of this study is to evaluate the efficacy of zanubrutinib added to standard of care as measured by complete renal response for participants with active proliferative lupus nephritis
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 177 (actual)
- First submitted
- 18 Nov 2020
- Start date
- 22 Dec 2020
- Primary completion date
- 26 Feb 2024
- Lead sponsor
- BeiGene
- Diseases
- Lupus (SLE)
- NCT number
- NCT04643470
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 177
- From 22 Dec 2020 to the primary completion date, 26 Feb 2024
- 44 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any other inflammatory diseases that might confound the assessments of efficacy, including but not limited to rheumatoid arthritis, myositis, vasculitis, or overlapping syndrome.
- Severe extrarenal SLE, including but not limited to severe pulmonary arterial hypertension, severe myocarditis, severe central nervous system lupus (such as neuropsychiatric SLE, seizures, psychosis, transverse myelitis, central nervous system vasculitis and optic neuritis), etc.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Other
- Glomerulonephritis caused by reasons other than systemic lupus erythematous.
- Sclerosis in \>50% of glomeruli on renal biopsy.
Who the study is looking for
- Clinical diagnosis of SLE according to the Systemic Lupus International Collaborating Clinics 2012 criteria.
- ISN/RPS 2003 Class III/IV lupus nephritis \[Type III(A), III (A+C), IV (A), and IV (A+C)\], with or without Class V, as confirmed by a renal biopsy.
- Positive antinuclear antibodies, positive anti-dsDNA autoantibody, and/or positive anti Smith autoantibody at screening
- Has 24-hour urine protein excretion \> 1.0 g at screening.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (44)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University Peoples Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking University International Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The Second Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| The Second Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| West China Hospital,Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| First Affiliated Hospital of Dalian Medical University Coordinator of this site? Confirm its status | Dalian | China | Unknown status |
| The First Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Guangdong Province Traditional Chinese Medical Hospitsal Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North) Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The Third Affiliated Hospital,Sun Yat-Sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Guangdong Provincial Peoples Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Guizhou Provincial Peoples Hospital Coordinator of this site? Confirm its status | Guiyang | China | Unknown status |
| Hainan General Hospital Coordinator of this site? Confirm its status | Haikou | China | Unknown status |
| The First Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Anhui Provincial Hospital Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| Jiangmen Central Hospital Coordinator of this site? Confirm its status | Jiangmen | China | Unknown status |
| Shandong Provincial Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| First Affiliated Hospital of Kunming Medical University Coordinator of this site? Confirm its status | Kunming | China | Unknown status |
| Liuzhou Workers Hospital Coordinator of this site? Confirm its status | Liuzhou | China | Unknown status |
| The First Affiliated Hospital of Nanchang University Branch Donghu Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| The Second Affiliated Hospital of Nanchang University Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| General Hospital of Eastern Theater Command Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Jiangsu Province Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| The Peoples Hospital of Guangxi Zhuang Autonomous Region Coordinator of this site? Confirm its status | Nanning | China | Unknown status |
| Ningbo First Hospital Coordinator of this site? Confirm its status | Ningbo | China | Unknown status |
| The Affiliated Hospital of Qingdao University Branch South Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
| Shanghai General Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Huashan Hospital Affiliated to Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shengjing Hospital Of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| The Second Peoples Hospital of Shenzhen Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
| Peking University Shenzhen Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
| Second hospital of Shanxi Medical University Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| The Second Affiliated Hospital of Tianjin Medical University Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| The First Affiliated Hospital of Xinjiang Medical University Coordinator of this site? Confirm its status | Ürümqi | China | Unknown status |
| Renmin Hospital of Wuhan University Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Wuxi Peoples Hospital Coordinator of this site? Confirm its status | Wuxi | China | Unknown status |
| Zhongshan Hospital Xiamen University Coordinator of this site? Confirm its status | Xiamen | China | Unknown status |
| The First Affiliated hospital of Xiamen University Coordinator of this site? Confirm its status | Xiamen | China | Unknown status |
| The First Affiliated Hospital of Xian Jiaotong University Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| The Second Affiliated Hospital of XiAn Jiaotong University Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| The affiliated hospital of xuzhou medical university Coordinator of this site? Confirm its status | Xuzhou | China | Unknown status |
| General Hospital of Ningxia Medical University Coordinator of this site? Confirm its status | Yinchuan | China | Unknown status |
| The First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.