A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Telitacicept in Patients With Primary IgA Nephropathy

Status: Active_not_recruiting
Location: See all (101) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to evaluate the efficacy and safety of Telitacicept in patients with primary IgA nephropathy at risk of progressing to end-stage renal disease(ESRD), despite maximum tolerated treatment with renin-angiotensin system(RAS) blockade using angiotensin converting enzyme inhibitors (ACEIs) or angiotensin II type I receptor blockers (ARBs).

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

• Voluntary informed consent provided;

• Male or female aged ≥ 18 years old;

• IgA nephropathy confirmed by pathological biopsy;

• During the screening period, UPCR ≥ 0.8 g/g or 24-hour urine protein ≥ 1.0 g/day based on 24-hour urine collection at Visit 1 and/or Visit 2 and at Visit 3;

• eGFR ≥ 30 mL/min per 1.73 m\^2 (using the CKD-EPI);

• Have been on a treatment regimen including ACEI/ARB for 12 weeks and on a stable use of ACEI/ARB medication at the maximum tolerated dose/maximum allowable dose within 4 weeks prior to randomization. Subjects who use both ACEIs and ARBs will be excluded.

Locations
Other Locations
China
Affiliated Hospital of Hebei University
Baoding
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
Baotou
Beijing Anzhen Hospital Affiliated to Capital Medical University
Beijing
Beijing Hospital
Beijing
Beijing Tsinghua Changgung Hospital
Beijing
Peking University First Hospital
Beijing
Peking University People's Hospital
Beijing
Peking University Shougang Hospital
Beijing
The First Affiliated Hospital of Bengbu Medical University
Bengbu
Cangzhou Central Hospital
Cangzhou
China-Japan Union Hospital of Jilin University
Changchun
Jilin Province People's Hospital
Changchun
The First Hospital of Jilin University
Changchun
The Second Hospital of Jilin University
Changchun
The Second Xiangya Hospital of Central South University
Changsha
The Third Xiangya Hospital of Central South University
Changsha
Xiangya Hospital of Central South University
Changsha
Changzhou No.2 People's Hospital
Changzhou
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu
West China Hospital of Sichuan University
Chengdu
The First Affiliated Hospital of Army Medical University
Chongqing
The Second Affiliated Hospital of Chongqing Medical University
Chongqing
Guangdong Provincial People's Hospital
Guangzhou
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou
The Third Affiliated Hospital of Southern Medical University
Guangzhou
Zhujiang Hospital of Southern Medical University
Guangzhou
The First Affiliated Hospital of Guilin Medical University
Guilin
Guizhou Provincial People's Hospital
Guiyang
Handan First Hospital
Handan
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou
Tongde Hospital of Zhejing Province
Hangzhou
Zhejiang Provincial People's Hospital
Hangzhou
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei
The Second Hospital of Anhui Medical University
Hefei
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot
Qilu Hospital of Shandong University
Jinan
Shandong Provincial Hospital
Jinan
Shandong Provincial Qianfoshan Hospital
Jinan
Jinhua Municipal Central Hospital
Jinhua
The First People's Hospital of Yunnan Province
Kunming
Gansu Provincial Hospital
Lanzhou
Lanzhou University Second Hospital
Lanzhou
The First Hospital of Lanzhou University
Lanzhou
Linyi People's Hospital
Linyi
Liuzhou Workers' Hospital
Liuchow
The First Affiliated Hospital of Henan University of science and Technology
Luoyang
Jiangxi Provincial People's Hospital
Nanchang
The First Affiliated Hospital of Nanchang University
Nanchang
The Second Affiliated Hospital of Nanchang University
Nanchang
Jiangsu Provincial People's Hospital
Nanjing
Zhongda Hospital Southeast University
Nanjing
The First Affiliated Hospital of Guangxi Medical University
Nanning
Nanyang Central Hospital
Nanyang
Ningbo Municipal Hospital of Traditional Chinese Medicine
Ningbo
Ningbo No.2 Hospital
Ningbo
The First Affiliated Hospital of Ningbo University
Ningbo
The Affiliated Hospital of Qingdao University
Qingdao
First Hospital of Qinhuangdao
Qinhuangdao
Huashan Hospital,Fudan University
Shanghai
Renji Hospital,Shanghai Jiaotong University School of Medicine
Shanghai
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai
Shantou Central Hospital
Shantou
General Hospital of Northern Theatre Command
Shenyang
Shengjing Hospital of China Medical University
Shenyang
The Affiliated Central Hospital of Shenyang Medical College
Shenyang
Longgang District People's Hospital of Shenzhen
Shenzhen
Peking University Shenzhen Hospital
Shenzhen
Shenzhen Hospital of Southern Medical University
Shenzhen
Shenzhen People's Hospital
Shenzhen
The Second Hospital of Hebei Medical University
Shijiazhuang
First Hospital of Shanxi Medical University
Taiyuan
Second Hospital of Shanxi Medical University
Taiyuan
Shanxi Bethune Hospital
Taiyuan
Shanxi Provincial People's Hospital
Taiyuan
Taizhou Hospital of Zhejiang Province
Taizhou
The Second Hospital of Tianjin Medical University
Tianjin
Tianjin Medical University General Hospital
Tianjin
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi
First Affiliated Hospital of Wenzhou Medical University
Wenzhou
Wenzhou Central Hospital
Wenzhou
Wenzhou People's Hospital
Wenzhou
Renmin Hospital of Wuhan University
Wuhan
Zhongnan Hospital of Wuhan University
Wuhan
The First Affiliated Hospital of Wannan Medical College
Wuhu
Wuxi People's Hospital
Wuxi
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an
The First Affiliated Hospital of Xiamen University
Xiamen
Zhongshan Hospital Xiamen University
Xiamen
Xingtai People's Hospital
Xingtai
The Affiliated Hospital of Xuzhou Medical University
Xuzhou
Yantai Yuhuangding Hospital
Yantai
The Second People's Hospital of Yibin
Yibin
General Hospital of Ningxia Medical University
Yinchuan
The First Affiliated Hospital of Hebei North University
Zhangjiakou
Affiliated Hospital of Guangdong Medical University
Zhanjiang
Henan Provincial People's Hospital
Zhengzhou
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Zhuhai People's Hospital
Zhuhai
Affiliated Hospital of Zunyi Medical University
Zunyi
Time Frame
Start Date: 2023-04-28
Completion Date: 2026-06
Participants
Target number of participants: 318
Treatments
Experimental: Telitacicept
Subjects will be given Telitacicept 240 mg SC once a week in phase A for a total of 39 doses and once every 2 weeks in phase B for a total of 32 doses.
Placebo_comparator: Placebo
Subjects will be given placebo SC once a week in phase A for a total of 39 doses and once every 2 weeks in phase B for a total of 32 doses.
Related Therapeutic Areas
Sponsors
Leads: RemeGen Co., Ltd.

This content was sourced from clinicaltrials.gov

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