Zanubrutinib in Participants With Active Proliferative Lupus Nephritis
NCT ID: NCT04643470
Last Updated: 2024-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
177 participants
INTERVENTIONAL
2020-12-22
2024-08-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Zanubrutinib Low Dose
Participants will receive zanubrutinib 40 mg twice daily (BID) for 72 weeks
Zanubrutinib
Administered as specified in the treatment arm
Zanubrutinib High Dose
Participants will receive zanubrutinib 160 mg twice daily (BID) for 72 weeks
Zanubrutinib
Administered as specified in the treatment arm
Zanubrutinib Medium Dose
Participants will receive zanubrutinib 160 mg once daily (QD) for 72 weeks
Zanubrutinib
Administered as specified in the treatment arm
Placebo
Participants will receive placebo to match zanubrutinib for 72 weeks
Placebo
Placebo to match zanubrutinib
Interventions
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Zanubrutinib
Administered as specified in the treatment arm
Placebo
Placebo to match zanubrutinib
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Positive antinuclear antibodies, positive anti-dsDNA autoantibody, and/or positive anti Smith autoantibody at screening
4. Has 24-hour urine protein excretion \> 1.0 g at screening.
Exclusion Criteria
2. Sclerosis in \>50% of glomeruli on renal biopsy.
3. Any other inflammatory diseases that might confound the assessments of efficacy, including but not limited to rheumatoid arthritis, myositis, vasculitis, or overlapping syndrome.
4. 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.
18 Years
70 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Principal Investigators
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Zhen Yao, MD
Role: STUDY_DIRECTOR
BeiGene
Locations
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Anhui Provincial Hospital
Hefei, Anhui, China
Peking University Peoples Hospital
Beijing, Beijing Municipality, China
Peking University International Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Zhongshan Hospital Xiamen University
Xiamen, Fujian, China
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North)
Guangzhou, Guangdong, China
Guangdong Provincial Peoples Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat Sen University
Guangzhou, Guangdong, China
The Third Affiliated Hospital, Sun Yat Sen University
Guangzhou, Guangdong, China
Guangdong Province Traditional Chinese Medical Hospitsal
Guangzhou, Guangdong, China
Jiangmen Central Hospital
Jiangmen, Guangdong, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
The Second Peoples Hospital of Shenzhen
Shenzhen, Guangdong, China
Liuzhou Workers Hospital
Liuzhou, Guangxi, China
The Peoples Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
Guizhou Provincial Peoples Hospital
Guiyang, Guizhou, China
Hainan General Hospital
Haikou, Hainan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
General Hospital of Eastern Theater Command
Nanjing, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Wuxi Peoples Hospital
Wuxi, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The Second Hospital of Jilin University
Changchun, Jilin, China
First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
The Second Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, China
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, China
Shandong Provincial Hospital
Jinan, Shandong, China
The Affiliated Hospital of Qingdao University Branch South
Qingdao, Shandong, China
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, Sichuan, China
The Second Affiliated Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Ningbo First Hospital
Ningbo, Zhejiang, China
Countries
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Other Identifiers
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CTR20202662
Identifier Type: OTHER
Identifier Source: secondary_id
BGB-3111-217
Identifier Type: -
Identifier Source: org_study_id