A Study of Telitacicept in Patients With Primary IgA Nephropathy
IgA Nephropathy
About this trial
This is an interventional treatment trial for IgA Nephropathy focused on measuring Kidney Diseases, Autoimmune Diseases, Immune System Diseases
Eligibility Criteria
Inclusion Criteria: Voluntary informed consent provided; Male or female aged ≥ 18 years old; IgA nephropathy confirmed by pathological biopsy; During the screening period, UPCR ≥ 0.5 g/g 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. Exclusion Criteria: Subjects with clinically significant abnormal laboratory tests; Patients with secondary IgA nephropathy; Patients with other types of glomerular disease such as crescentic glomerulonephritis, minimal change nephropathy with IgA deposition; Renal transplant; Patients with cirrhosis, as assessed by the investigator; Patients who experienced any of the following cardiovascular and cerebrovascular events within 24 weeks prior to randomization: myocardial infarction, unstable angina, ventricular arrhythmia, NYHA Class II or higher heart failure, stroke, etc.; Sitting office SBP>140 mmHg or DBP>90 mmHg during the screening period; HbA1c>8% (64mmol/mol); Treatment with immunosuppressants (cyclophosphamide, azathioprine, mycophenolate, leflunomide, tacrolimus, cyclosporine, Tripterygium wilfordii, etc.) within 12 weeks prior to randomization; Treatment with anti-CD20 therapy within 24 weeks prior to randomization; Treatment with systemic glucocorticoid within 12 weeks prior to randomization; Hospitalization or intravenous anti-infective therapy for active infection within 4 weeks prior to randomization; Patients with active tuberculosis and untreated latent tuberculosis; Hepatitis B: patients with active hepatitis (patients with positive HBsAg) or latent hepatitis B (patients with positive HBcAb and positive HBV-DNA); Patients with hepatitis C; Patients with HIV; Patients with malignancy within the past 5 years, except for treated cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, colon polyps, or cervical cancer in situ; Pregnant women, lactating women, and subjects with childbearing plans during the trial; Unavoidable use of drugs with renal toxicity during the study; Allergic to biological products of human origin; Patients who have received any investigational therapy within 4 weeks or within 5 times the half-life of the investigational product (whichever is longer) prior to randomization; Live vaccination within 4 weeks prior to randomization; Patients with COVID-19 infection within 4 weeks of randomization or patients with a history of serious COVID-19 disease requiring hospitalization within 52 weeks prior to screening; Drug or alcohol abuse/dependence within 52 weeks prior to randomization; Not suitable for the study in the opinion of the investigator.
Sites / Locations
- The First Affiliated Hospital of Bengbu Medical College
- The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
- The Second Affiliated Hospital of Anhui Medical UniversityRecruiting
- Yijishan Hospital of Wannan Medical CollegeRecruiting
- Beijing Anzhen Hospital Affiliated to Capital Medical University
- Beijing Hospital
- Beijing Tsinghua Changgeng Hospital
- Peking University First HospitalRecruiting
- Peking University People's Hospital
- Peking University Shougang Hospital
- The First Affiliated Hospital of Army Medical University
- The Second Affiliated Hospital of Chongqing Medical University
- The First Affiliated Hospital of Xiamen University
- Zhongshan Hospital Affiliated to Xiamen UniversityRecruiting
- Gansu Provincial HospitalRecruiting
- Lanzhou University Second Hospital
- The First Hospital of Lanzhou University
- Guangdong Provincial People's HospitalRecruiting
- The Second Affiliated Hospital of Guangzhou Medical University
- The Third Affiliated Hospital of Southern Medical University
- Zhujiang Hospital of Southern Medical University
- Shantou Central Hospital
- Longgang District People's Hospital of Shenzhen
- Peking University Shenzhen Hospital
- Shenzhen Hospital of Southern Medical University
- Shenzhen People's Hospital
- Affiliated Hospital of Guangdong Medical University
- Zhuhai People's Hospital
- Affiliated Hospital of Guilin Medical CollegeRecruiting
- Liuzhou Workers HospitalRecruiting
- The First Affiliated Hospital of Guangxi Medical University
- Guizhou Provincial People's Hospital
- Affiliated Hospital of Zunyi Medical University
- Affiliated Hospital of Hebei University
- Cangzhou Central Hospital
- Handan First Hospital
- First Hospital of Qinhuangdao
- The Second Hospital of Hebei Medical UniversityRecruiting
- Xingtai People's Hospital
- The First Affiliated Hospital of Hebei North University
- The First Affiliated Hospital of Henan University of science and Technology
- Nanyang Central Hospital
- Henan Provincial People's Hospital
- The First Affiliated Hospital of Zhengzhou University
- Renmin Hospital of Wuhan UniversityRecruiting
- Zhongnan Hospital of Wuhan UniversityRecruiting
- The Second Xiangya Hospital of Central South University
- The Third Xiangya Hospital of Central South University
- Xiangya Hospital of Central South UniversityRecruiting
- The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and TechnologyRecruiting
- The Affiliated Hospital of Inner Mongolia Medical University
- Changzhou No.2 People's HospitalRecruiting
- Jiangsu Provincial People's Hospital
- Zhongda Hospital Southeast University
- Wuxi People's HospitalRecruiting
- The Affiliated Hospital of Xuzhou Medical University
- Jiangxi Provincial People's Hospital
- The First Affiliated Hospital of Nanchang University
- The Second Affiliated Hospital of Nanchang University
- China-Japan Union Hospital of Jilin UniversityRecruiting
- Jilin Province People's Hospital
- The First Hospital of Jilin University
- The Second Hospital of Jilin UniversityRecruiting
- General Hospital of Northern Theatre Command of Chinese People's Liberation Army
- Shengjing Hospital of China Medical UniversityRecruiting
- The Affiliated Central Hospital of Shenyang Medical College
- General Hospital of Ningxia Medical University
- The First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting
- The Second Affiliated Hospital of Xi'an Jiaotong University
- Qilu Hospital of Shandong UniversityRecruiting
- Shandong Provincial Hospital
- Shandong Provincial Qianfoshan Hospital
- Linyi People's HospitalRecruiting
- The Affiliated Hospital of Qingdao UniversityRecruiting
- Yantai Yuhuangding Hospital
- Huashan Hospital Affiliated to Fudan University
- Renji Hospital Affiliated to Shanghai Jiaotong University School of MedicineRecruiting
- Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
- First Hospital of Shanxi Medical University
- Second Hospital of Shanxi Medical University
- Shanxi Bethune HospitalRecruiting
- Shanxi Provincial People's HospitalRecruiting
- Sichuan Academy of Medical Sciences & Sichuan Provincial People's HospitalRecruiting
- West China Hospital of Sichuan University
- The Second People's Hospital of Yibin
- The Second Hospital of Tianjin Medical University
- Tianjin Medical University General HospitalRecruiting
- People's Hospital of Xinjiang Uygur Autonomous RegionRecruiting
- The First Affiliated Hospital of Xinjiang Medical University
- The First People's Hospital of Yunnan Province
- The First Affiliated Hospital, Zhejiang University School of Medicine
- Zhejiang Provincial People's Hospital
- Jinhua Municipal Central HospitalRecruiting
- Ningbo First Hospital
- Ningbo No.2 Hospital
- Ningbo Traditional Chinese Medicine Hospital
- Taizhou Hospital of Zhejiang Province
- The First Affiliated Hospital of Wenzhou Medical UniversityRecruiting
- Wenzhou Central Hospital
- Wenzhou People's HospitalRecruiting
- Tongde Hospital of Zhejing Province
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Telitacicept
Placebo
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.
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.