A Multicenter, Randomized, Controlled, Open Phase II/III Clinical Study to Evaluate the Efficacy and Safety of B007 Versus Cyclosporine in the Treatment of Primary Membranous Nephropathy.

Status: Recruiting
Location: See all (21) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

To evaluate the efficacy and safety of B007 in the Treatment of Primary Membranous Nephropathy

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Subjects with primary membranous nephropathy pathologically confirmed by renal biopsy;

• Subjects with glomerular filtration rate(eGFR) ≥ 45 mL/min/1.73 m2.

• If taking Angiotensin converting enzyme inhibitors/angiotensin II receptor antagonists/sodium-glucose cotransporter 2 inhibitors/endothelin inhibitors, a stable dose within 4 weeks before randomization;

• Subjects with 24-hour elevated urinary protein in accordance with the prescribed conditions;

• Subjects whose laboratory test results meet the prescribed standards during the screening period;

• Subjects who have fully understood this study and voluntarily signed the informed consent form;

• Subjects who are able to follow the study protocol as judged by the investigator.

Locations
Other Locations
China
Beijing Tsinghua Changgung Hospital
RECRUITING
Beijing
Peking university first hospital
RECRUITING
Beijing
The Second Norman Bethune Hospital of Jilin University
RECRUITING
Changchun
The First Affiliated Hospital, Sun Yat-sen University
RECRUITING
Guangzhou
Zhujiang Hospital of Southern Medical University
RECRUITING
Guangzhou
Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine
RECRUITING
Hangzhou
The First Affiliated Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
Shandong Provincial Hospital
RECRUITING
Jinan
The First Affiliated Hospital of Guangxi Medical University
RECRUITING
Nanning
Affiliated Hospital of Nantong University
RECRUITING
Nantong
The Affiliated Hospital of Qingdao University
RECRUITING
Qingdao
Northern Theater Command General Hospital
RECRUITING
Shenyang
Shengjing Hospital affiliated to China Medical University
RECRUITING
Shenyang
Peking University Shenzhen Hospital
RECRUITING
Shenzhen
Renmin Hospital of Wuhan University
RECRUITING
Wuhan
Wuxi People's Hospital
RECRUITING
Wuxi
Xi'an Daxing Hospital
RECRUITING
Xi'an
The Second Affiliated Hospital of Xingtai Medical college
RECRUITING
Xingtai
Northern Jiangsu People's Hospital
RECRUITING
Yangzhou
Yantai Yuhuangding Hospital
RECRUITING
Yantai
The First People's Hospital of Zigong
RECRUITING
Zigong
Contact Information
Primary
Minghui Zhao
bdyyec@163.com
0086- 010-66119025
Time Frame
Start Date: 2024-07-30
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 216
Treatments
Experimental: B007
Active_comparator: Cyclosporin Capsules
Sponsors
Leads: Shanghai Jiaolian Drug Research and Development Co., Ltd
Collaborators: Shanghai Pharmaceuticals Holding Co., Ltd

This content was sourced from clinicaltrials.gov