Phase
Condition
Idiopathic Membranous Nephropathy
Nephrotic Syndrome
Glomerulonephritis
Treatment
B007
Cyclosporin Capsules
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects with primary membranous nephropathy pathologically confirmed by renalbiopsy;
Subjects with glomerular filtration rate(eGFR) ≥ 45 mL/min/1.73 m2.
If taking Angiotensin converting enzyme inhibitors/angiotensin II receptorantagonists/sodium-glucose cotransporter 2 inhibitors/endothelin inhibitors, astable dose within 4 weeks before randomization;
Subjects with 24-hour elevated urinary protein in accordance with the prescribedconditions;
Subjects whose laboratory test results meet the prescribed standards during thescreening period;
Subjects who have fully understood this study and voluntarily signed the informedconsent form;
Subjects who are able to follow the study protocol as judged by the investigator.
Exclusion
Exclusion Criteria:
Subjects with secondary membranous nephropathy or primary membranous nephropathywhose pathological reports suggest concomitant crescent bodies;
Subjects identified by the investigator as previously resistant to CD20 monoclonalantibody or cyclosporine;
Subjects who have received medication prescribed for membranous nephropathy;
Subjects with concomitant prescribed diseases;
Subjects with a known history of severe allergic reactions to humanized monoclonalantibodies, or known allergies to any component of cyclosporine or B007;
Subjects who received live vaccination, major surgery, or participated in otherclinical trials within 28 days before receiving the study drug;
Subjects with positive hepatitis B surface antigen; those with positive hepatitis Cvirus antibody; those with a history of immunodeficiency or suffer from otheracquired or congenital immunodeficiency diseases;
Subjects who have a clear history of tuberculosis or have received anti-tuberculosistreatment;
Subjects with CD4+ T lymphocyte count < 400 cells/μL;
Pregnant or lactating women; women of childbearing potential who have not beensterilized do not agree to use appropriate contraceptive measures during treatmentand for at least 12 months after the last dose of the study drug;
For male subjects who have not been sterilized: those who do not consent to the useof barrier contraception during the study period and for at least 12 months afterthe last administration of the study drug, and who do not consent to the use ofother contraceptive methods by their spouses;
Other conditions unsuitable for participation in this study determined by theInvestigator.
Study Design
Connect with a study center
Beijing Tsinghua Changgung Hospital
Beijing,
ChinaActive - Recruiting
Peking university first hospital
Beijing,
ChinaActive - Recruiting
The Second Norman Bethune Hospital of Jilin University
Chang chun,
ChinaActive - Recruiting
The First Affiliated Hospital of Dalian Medical University
Dalian,
ChinaSite Not Available
Guangdong Provincial People's Hospital
Guangzhou,
ChinaActive - Recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou,
ChinaActive - Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou,
ChinaActive - Recruiting
Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine
Hangzhou,
ChinaActive - Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou,
ChinaActive - Recruiting
Shandong Provincial Hospital
Jinan,
ChinaActive - Recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning,
ChinaActive - Recruiting
Affiliated Hospital of Nantong University
Nantong,
ChinaActive - Recruiting
The Affiliated Hospital of Qingdao University
Qingdao,
ChinaActive - Recruiting
Northern Theater Command General Hospital
Shenyang,
ChinaActive - Recruiting
Shengjing Hospital affiliated to China Medical University
Shenyang,
ChinaActive - Recruiting
Peking University Shenzhen Hospital
Shenzhen,
ChinaActive - Recruiting
Renmin Hospital of Wuhan University
Wuhan,
ChinaActive - Recruiting
Wuxi People's Hospital
Wuxi,
ChinaActive - Recruiting
Xi'an Daxing Hospital
Xi'an,
ChinaActive - Recruiting
The Second Affiliated Hospital of Xingtai Medical college
Xingtai,
ChinaActive - Recruiting
Northern Jiangsu People's Hospital
Yangzhou,
ChinaActive - Recruiting
Yantai Yuhuangding Hospital
Yantai,
ChinaActive - Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou,
ChinaSite Not Available
The First People's Hospital of Zigong
Zigong,
ChinaActive - Recruiting
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