Phase
Condition
Nephropathy
Kidney Disease
Nephritis
Treatment
Placebo
Telitacicept
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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/daybased 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 useof ACEI/ARB medication at the maximum tolerated dose/maximum allowable dose within 4weeks prior to randomization. Subjects who use both ACEIs and ARBs will be excluded.
Exclusion
Exclusion Criteria:
Clinically significant abnormal laboratory tests;
Secondary IgA nephropathy;
Other types of glomerular disease such as crescentic glomerulonephritis(>50%),minimal change nephropathy with IgA deposition;
Renal transplant;
Cirrhosis, as assessed by the investigator;
Experienced any of the following cardiovascular and cerebrovascular events within 24weeks prior to randomization: myocardial infarction, unstable angina, ventriculararrhythmia, New York Heart Association(NYHA) Class II or higher heart failure,stroke, etc.;
Sitting position SBP>140 mmHg or DBP>90 mmHg for at least once at 2 visits duringthe screening period;
Poorly controlled type 1 and type 2 diabetes (glycated hemoglobin A1c[HbA1c]>8% or 64mmol/mol);
Received immunosuppressants within 12 weeks prior to randomization, including butnot limited to cyclophosphamide, azathioprine, mycophenolate, leflunomide,tacrolimus, cyclosporine, Tripterygium wilfordii;
Received anti-CD20 therapy (for example, Rituximab Injection) within 24 weeks priorto randomization;
Received systemic glucocorticoid treatment within 12 weeks prior to randomization,excluding the followings: ① received systemic treatment with prednisolone ≤ 0.5mg/kgor equivalent glucocorticoid for non- IgA nephropathy for no more than 3 courses (≤ 2 weeks per course) in the past 52 weeks; ② topical administration or nasalinhalation;
Hospitalization or intravenous anti-infective therapy for active infection within 4weeks prior to randomization;
Active tuberculosis and untreated latent tuberculosis;
Hepatitis B: patients with active hepatitis (patients with positive HBsAg) or latenthepatitis B (patients with positive HBcAb and positive HBV-DNA);
Hepatitis C;
Patients with HIV;
Malignancy within the past 5 years, except for treated cutaneous basal cellcarcinoma, cutaneous squamous cell carcinoma, colon polyps, or cervical cancer insitu;
Pregnant women, lactating women, and subjects with childbearing plans during thetrial;
Allergic to biological products of human origin;
Received any investigational therapy within 4 weeks or within 5 times the half-lifeof the investigational product (whichever is longer) prior to randomization;
Received live vaccination within 4 weeks prior to randomization;
Drug or alcohol abuse/dependence within 52 weeks prior to randomization;
Not suitable for the study in the opinion of the investigator.
Study Design
Study Description
Connect with a study center
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui
ChinaSite Not Available
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui
ChinaSite Not Available
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui
ChinaSite Not Available
Yijishan Hospital of Wannan Medical College
Wuhu, Anhui
ChinaSite Not Available
Beijing Anzhen Hospital Affiliated to Capital Medical University
Beijing, Beijing
ChinaSite Not Available
Beijing Hospital
Beijing, Beijing
ChinaSite Not Available
Beijing Tsinghua Changgeng Hospital
Beijing, Beijing
ChinaSite Not Available
Peking University First Hospital
Beijing, Beijing
ChinaSite Not Available
Peking University People's Hospital
Beijing, Beijing
ChinaSite Not Available
Peking University Shougang Hospital
Beijing, Beijing
ChinaSite Not Available
The First Affiliated Hospital of Army Medical University
Chongqing, Chongqing
ChinaSite Not Available
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing
ChinaSite Not Available
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian
ChinaSite Not Available
Zhongshan Hospital Affiliated to Xiamen University
Xiamen, Fujian
ChinaSite Not Available
Gansu Provincial Hospital
Lanzhou, Gansu
ChinaSite Not Available
Lanzhou University Second Hospital
Lanzhou, Gansu
ChinaSite Not Available
The First Hospital of Lanzhou University
Lanzhou, Gansu
ChinaSite Not Available
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
ChinaSite Not Available
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
ChinaSite Not Available
The Third Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong
ChinaSite Not Available
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong
ChinaSite Not Available
Shantou Central Hospital
Shantou, Guangdong
ChinaSite Not Available
Longgang District People's Hospital of Shenzhen
Shenzhen, Guangdong
ChinaSite Not Available
Peking University Shenzhen Hospital
Shenzhen, Guangdong
ChinaSite Not Available
Shenzhen Hospital of Southern Medical University
Shenzhen, Guangdong
ChinaSite Not Available
Shenzhen People's Hospital
Shenzhen, Guangdong
ChinaSite Not Available
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong
ChinaSite Not Available
Zhuhai People's Hospital
Zhuhai, Guangdong
ChinaSite Not Available
Affiliated Hospital of Guilin Medical College
Guilin, Guangxi Zhuang Autonomous Region
ChinaSite Not Available
Liuzhou Workers Hospital
Liuzhou, Guangxi Zhuang Autonomous Region
ChinaSite Not Available
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi Zhuang Autonomous Region
ChinaSite Not Available
Guizhou Provincial People's Hospital
Guiyang, Guizhou
ChinaSite Not Available
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou
ChinaSite Not Available
Affiliated Hospital of Hebei University
Baoding, Hebei
ChinaSite Not Available
Cangzhou Central Hospital
Cangzhou, Hebei
ChinaSite Not Available
Handan First Hospital
Handan, Hebei
ChinaSite Not Available
First Hospital of Qinhuangdao
Qinhuangdao, Hebei
ChinaSite Not Available
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei
ChinaSite Not Available
Xingtai People's Hospital
Xingtai, Hebei
ChinaSite Not Available
The First Affiliated Hospital of Hebei North University
Zhangjiakou, Hebei
ChinaSite Not Available
The First Affiliated Hospital of Henan University of science and Technology
Luoyang, Henan
ChinaSite Not Available
Nanyang Central Hospital
Nanyang, Henan
ChinaSite Not Available
Henan Provincial People's Hospital
Zhengzhou, Henan
ChinaSite Not Available
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
ChinaSite Not Available
Renmin Hospital of Wuhan University
Wuhan, Hubei
ChinaSite Not Available
Zhongnan Hospital of Wuhan University
Wuhan, Hubei
ChinaSite Not Available
The Second Xiangya Hospital of Central South University
Changsha, Hunan
ChinaSite Not Available
The Third Xiangya Hospital of Central South University
Changsha, Hunan
ChinaSite Not Available
Xiangya Hospital of Central South University
Changsha, Hunan
ChinaSite Not Available
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
Baotou, Inner Mongolia Autonomous Region
ChinaSite Not Available
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia Autonomous Region
ChinaSite Not Available
Changzhou No.2 People's Hospital
Changzhou, Jiangsu
ChinaSite Not Available
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu
ChinaSite Not Available
Zhongda Hospital Southeast University
Nanjing, Jiangsu
ChinaSite Not Available
Wuxi People's Hospital
Wuxi, Jiangsu
ChinaSite Not Available
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
ChinaSite Not Available
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi
ChinaSite Not Available
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
ChinaSite Not Available
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
ChinaSite Not Available
China-Japan Union Hospital of Jilin University
Changchun, Jilin
ChinaSite Not Available
Jilin Province People's Hospital
Changchun, Jilin
ChinaSite Not Available
The First Hospital of Jilin University
Changchun, Jilin
ChinaSite Not Available
The Second Hospital of Jilin University
Changchun, Jilin
ChinaSite Not Available
General Hospital of Northern Theatre Command of Chinese People's Liberation Army
Shenyang, Liaoning
ChinaSite Not Available
Shengjing Hospital of China Medical University
Shenyang, Liaoning
ChinaSite Not Available
The Affiliated Central Hospital of Shenyang Medical College
Shenyang, Liaoning
ChinaSite Not Available
General Hospital of Ningxia Medical University
Yinchuan, Ningxia Hui Autonomous Region
ChinaSite Not Available
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi
ChinaSite Not Available
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi
ChinaSite Not Available
Qilu Hospital of Shandong University
Jinan, Shandong
ChinaSite Not Available
Shandong Provincial Hospital
Jinan, Shandong
ChinaSite Not Available
Shandong Provincial Qianfoshan Hospital
Jinan, Shandong
ChinaSite Not Available
Linyi People's Hospital
Linyi, Shandong
ChinaSite Not Available
The Affiliated Hospital of Qingdao University
Qingdao, Shandong
ChinaSite Not Available
Yantai Yuhuangding Hospital
Yantai, Shandong
ChinaSite Not Available
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai
ChinaSite Not Available
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai
ChinaSite Not Available
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai
ChinaSite Not Available
First Hospital of Shanxi Medical University
Taiyuan, Shanxi
ChinaSite Not Available
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi
ChinaSite Not Available
Shanxi Bethune Hospital
Taiyuan, Shanxi
ChinaSite Not Available
Shanxi Provincial People's Hospital
Taiyuan, Shanxi
ChinaSite Not Available
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, Sichuan
ChinaSite Not Available
West China Hospital of Sichuan University
Chengdu, Sichuan
ChinaSite Not Available
The Second People's Hospital of Yibin
Yibin, Sichuan
ChinaSite Not Available
The Second Hospital of Tianjin Medical University
Tianjin, Tianjin
ChinaSite Not Available
Tianjin Medical University General Hospital
Tianjin, Tianjin
ChinaSite Not Available
People's Hospital of Xinjiang Uygur Autonomous Region
Urumqi, Xinjiang Uygur Autonomous Region
ChinaSite Not Available
The First Affiliated Hospital of Xinjiang Medical University
Urumqi, Xinjiang Uygur Autonomous Region
ChinaSite Not Available
The First People's Hospital of Yunnan Province
Kunming, Yunnan
ChinaSite Not Available
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
ChinaSite Not Available
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang
ChinaSite Not Available
Jinhua Municipal Central Hospital
Jinhua, Zhejiang
ChinaSite Not Available
Ningbo First Hospital
Ningbo, Zhejiang
ChinaSite Not Available
Ningbo Huamei Hospital, University of Chinese Academy of Sciences
Ningbo, Zhejiang
ChinaSite Not Available
Ningbo No.2 Hospital
Ningbo, Zhejiang
ChinaSite Not Available
Ningbo Traditional Chinese Medicine Hospital
Ningbo, Zhejiang
ChinaSite Not Available
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang
ChinaSite Not Available
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
ChinaSite Not Available
Wenzhou Central Hospital
Wenzhou, Zhejiang
ChinaSite Not Available
Wenzhou People's Hospital
Wenzhou, Zhejiang
ChinaSite Not Available
Tongde Hospital of Zhejing Province
Hangzhou, Zhejing
ChinaSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.