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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

Full criteria on ClinicalTrials.gov

Sites (44)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Peking University Peoples Hospital
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BeijingChinaUnknown status
Peking University International Hospital
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BeijingChinaUnknown status
The Second Hospital of Jilin University
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ChangchunChinaUnknown status
The Second Xiangya Hospital of Central South University
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ChangshaChinaUnknown status
West China Hospital,Sichuan University
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ChengduChinaUnknown status
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
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ChengduChinaUnknown status
First Affiliated Hospital of Dalian Medical University
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DalianChinaUnknown status
The First Affiliated Hospital, Sun Yat-sen University
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GuangzhouChinaUnknown status
Guangdong Province Traditional Chinese Medical Hospitsal
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GuangzhouChinaUnknown status
Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North)
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GuangzhouChinaUnknown status
The Third Affiliated Hospital,Sun Yat-Sen University
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GuangzhouChinaUnknown status
Guangdong Provincial Peoples Hospital
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GuangzhouChinaUnknown status
Guizhou Provincial Peoples Hospital
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GuiyangChinaUnknown status
Hainan General Hospital
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HaikouChinaUnknown status
The First Affiliated Hospital Zhejiang University School of Medicine
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HangzhouChinaUnknown status
Anhui Provincial Hospital
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HefeiChinaUnknown status
Jiangmen Central Hospital
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JiangmenChinaUnknown status
Shandong Provincial Hospital
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JinanChinaUnknown status
First Affiliated Hospital of Kunming Medical University
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KunmingChinaUnknown status
Liuzhou Workers Hospital
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LiuzhouChinaUnknown status
The First Affiliated Hospital of Nanchang University Branch Donghu
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NanchangChinaUnknown status
The Second Affiliated Hospital of Nanchang University
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NanchangChinaUnknown status
General Hospital of Eastern Theater Command
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NanjingChinaUnknown status
Jiangsu Province Hospital
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NanjingChinaUnknown status
The Peoples Hospital of Guangxi Zhuang Autonomous Region
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NanningChinaUnknown status
Ningbo First Hospital
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NingboChinaUnknown status
The Affiliated Hospital of Qingdao University Branch South
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QingdaoChinaUnknown status
Shanghai General Hospital
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ShanghaiChinaUnknown status
Huashan Hospital Affiliated to Fudan University
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ShanghaiChinaUnknown status
Shengjing Hospital Of China Medical University
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ShenyangChinaUnknown status
The Second Peoples Hospital of Shenzhen
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ShenzhenChinaUnknown status
Peking University Shenzhen Hospital
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ShenzhenChinaUnknown status
Second hospital of Shanxi Medical University
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TaiyuanChinaUnknown status
The Second Affiliated Hospital of Tianjin Medical University
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TianjinChinaUnknown status
The First Affiliated Hospital of Xinjiang Medical University
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ÜrümqiChinaUnknown status
Renmin Hospital of Wuhan University
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WuhanChinaUnknown status
Wuxi Peoples Hospital
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WuxiChinaUnknown status
Zhongshan Hospital Xiamen University
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XiamenChinaUnknown status
The First Affiliated hospital of Xiamen University
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XiamenChinaUnknown status
The First Affiliated Hospital of Xian Jiaotong University
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Xi'anChinaUnknown status
The Second Affiliated Hospital of XiAn Jiaotong University
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Xi'anChinaUnknown status
The affiliated hospital of xuzhou medical university
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XuzhouChinaUnknown status
General Hospital of Ningxia Medical University
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YinchuanChinaUnknown status
The First Affiliated Hospital of Zhengzhou University
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ZhengzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.