A Study of Telitacicept in Patients with Primary Immunoglobulin A(IgA) Nephropathy

Last updated: September 12, 2024
Sponsor: RemeGen Co., Ltd.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Nephropathy

Kidney Disease

Nephritis

Treatment

Placebo

Telitacicept

Clinical Study ID

NCT05799287
18C021
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Voluntary informed consent provided;

  2. Male or female aged ≥ 18 years old;

  3. IgA nephropathy confirmed by pathological biopsy;

  4. 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;

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

  6. 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:

  1. Clinically significant abnormal laboratory tests;

  2. Secondary IgA nephropathy;

  3. Other types of glomerular disease such as crescentic glomerulonephritis(>50%),minimal change nephropathy with IgA deposition;

  4. Renal transplant;

  5. Cirrhosis, as assessed by the investigator;

  6. 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.;

  7. Sitting position SBP>140 mmHg or DBP>90 mmHg for at least once at 2 visits duringthe screening period;

  8. Poorly controlled type 1 and type 2 diabetes (glycated hemoglobin A1c[HbA1c]>8% or 64mmol/mol);

  9. Received immunosuppressants within 12 weeks prior to randomization, including butnot limited to cyclophosphamide, azathioprine, mycophenolate, leflunomide,tacrolimus, cyclosporine, Tripterygium wilfordii;

  10. Received anti-CD20 therapy (for example, Rituximab Injection) within 24 weeks priorto randomization;

  11. 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;

  12. Hospitalization or intravenous anti-infective therapy for active infection within 4weeks prior to randomization;

  13. Active tuberculosis and untreated latent tuberculosis;

  14. Hepatitis B: patients with active hepatitis (patients with positive HBsAg) or latenthepatitis B (patients with positive HBcAb and positive HBV-DNA);

  15. Hepatitis C;

  16. Patients with HIV;

  17. Malignancy within the past 5 years, except for treated cutaneous basal cellcarcinoma, cutaneous squamous cell carcinoma, colon polyps, or cervical cancer insitu;

  18. Pregnant women, lactating women, and subjects with childbearing plans during thetrial;

  19. Allergic to biological products of human origin;

  20. Received any investigational therapy within 4 weeks or within 5 times the half-lifeof the investigational product (whichever is longer) prior to randomization;

  21. Received live vaccination within 4 weeks prior to randomization;

  22. Drug or alcohol abuse/dependence within 52 weeks prior to randomization;

  23. Not suitable for the study in the opinion of the investigator.

Study Design

Total Participants: 318
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
April 28, 2023
Estimated Completion Date:
December 31, 2025

Study Description

This study consists of a 5-week screening period, a double-blind treatment period divided into phase A and phase B. Eligible subjects will be randomly assigned in a 1:1 ratio to receive either Telitacicept 240mg or placebo. Subjects will be given subcutaneous injection(SC) Telitacicept or placebo once a week for a total of 39 doses in phase A and once every 2 weeks for a total of 32 doses in phase B.

Primary endpoint of phase A will be measured at week 39. Primary endpoint of phase B will be measured at week 104.

Connect with a study center

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui
    China

    Site Not Available

  • The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)

    Hefei, Anhui
    China

    Site Not Available

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui
    China

    Site Not Available

  • Yijishan Hospital of Wannan Medical College

    Wuhu, Anhui
    China

    Site Not Available

  • Beijing Anzhen Hospital Affiliated to Capital Medical University

    Beijing, Beijing
    China

    Site Not Available

  • Beijing Hospital

    Beijing, Beijing
    China

    Site Not Available

  • Beijing Tsinghua Changgeng Hospital

    Beijing, Beijing
    China

    Site Not Available

  • Peking University First Hospital

    Beijing, Beijing
    China

    Site Not Available

  • Peking University People's Hospital

    Beijing, Beijing
    China

    Site Not Available

  • Peking University Shougang Hospital

    Beijing, Beijing
    China

    Site Not Available

  • The First Affiliated Hospital of Army Medical University

    Chongqing, Chongqing
    China

    Site Not Available

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing
    China

    Site Not Available

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian
    China

    Site Not Available

  • Zhongshan Hospital Affiliated to Xiamen University

    Xiamen, Fujian
    China

    Site Not Available

  • Gansu Provincial Hospital

    Lanzhou, Gansu
    China

    Site Not Available

  • Lanzhou University Second Hospital

    Lanzhou, Gansu
    China

    Site Not Available

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu
    China

    Site Not Available

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong
    China

    Site Not Available

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong
    China

    Site Not Available

  • The Third Affiliated Hospital of Southern Medical University

    Guangzhou, Guangdong
    China

    Site Not Available

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong
    China

    Site Not Available

  • Shantou Central Hospital

    Shantou, Guangdong
    China

    Site Not Available

  • Longgang District People's Hospital of Shenzhen

    Shenzhen, Guangdong
    China

    Site Not Available

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong
    China

    Site Not Available

  • Shenzhen Hospital of Southern Medical University

    Shenzhen, Guangdong
    China

    Site Not Available

  • Shenzhen People's Hospital

    Shenzhen, Guangdong
    China

    Site Not Available

  • Affiliated Hospital of Guangdong Medical University

    Zhanjiang, Guangdong
    China

    Site Not Available

  • Zhuhai People's Hospital

    Zhuhai, Guangdong
    China

    Site Not Available

  • Affiliated Hospital of Guilin Medical College

    Guilin, Guangxi Zhuang Autonomous Region
    China

    Site Not Available

  • Liuzhou Workers Hospital

    Liuzhou, Guangxi Zhuang Autonomous Region
    China

    Site Not Available

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi Zhuang Autonomous Region
    China

    Site Not Available

  • Guizhou Provincial People's Hospital

    Guiyang, Guizhou
    China

    Site Not Available

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, Guizhou
    China

    Site Not Available

  • Affiliated Hospital of Hebei University

    Baoding, Hebei
    China

    Site Not Available

  • Cangzhou Central Hospital

    Cangzhou, Hebei
    China

    Site Not Available

  • Handan First Hospital

    Handan, Hebei
    China

    Site Not Available

  • First Hospital of Qinhuangdao

    Qinhuangdao, Hebei
    China

    Site Not Available

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei
    China

    Site Not Available

  • Xingtai People's Hospital

    Xingtai, Hebei
    China

    Site Not Available

  • The First Affiliated Hospital of Hebei North University

    Zhangjiakou, Hebei
    China

    Site Not Available

  • The First Affiliated Hospital of Henan University of science and Technology

    Luoyang, Henan
    China

    Site Not Available

  • Nanyang Central Hospital

    Nanyang, Henan
    China

    Site Not Available

  • Henan Provincial People's Hospital

    Zhengzhou, Henan
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan
    China

    Site Not Available

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei
    China

    Site Not Available

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei
    China

    Site Not Available

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan
    China

    Site Not Available

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan
    China

    Site Not Available

  • Xiangya Hospital of Central South University

    Changsha, Hunan
    China

    Site Not Available

  • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology

    Baotou, Inner Mongolia Autonomous Region
    China

    Site Not Available

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia Autonomous Region
    China

    Site Not Available

  • Changzhou No.2 People's Hospital

    Changzhou, Jiangsu
    China

    Site Not Available

  • Jiangsu Provincial People's Hospital

    Nanjing, Jiangsu
    China

    Site Not Available

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu
    China

    Site Not Available

  • Wuxi People's Hospital

    Wuxi, Jiangsu
    China

    Site Not Available

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu
    China

    Site Not Available

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi
    China

    Site Not Available

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi
    China

    Site Not Available

  • China-Japan Union Hospital of Jilin University

    Changchun, Jilin
    China

    Site Not Available

  • Jilin Province People's Hospital

    Changchun, Jilin
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun, Jilin
    China

    Site Not Available

  • The Second Hospital of Jilin University

    Changchun, Jilin
    China

    Site Not Available

  • General Hospital of Northern Theatre Command of Chinese People's Liberation Army

    Shenyang, Liaoning
    China

    Site Not Available

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning
    China

    Site Not Available

  • The Affiliated Central Hospital of Shenyang Medical College

    Shenyang, Liaoning
    China

    Site Not Available

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia Hui Autonomous Region
    China

    Site Not Available

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi
    China

    Site Not Available

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi
    China

    Site Not Available

  • Qilu Hospital of Shandong University

    Jinan, Shandong
    China

    Site Not Available

  • Shandong Provincial Hospital

    Jinan, Shandong
    China

    Site Not Available

  • Shandong Provincial Qianfoshan Hospital

    Jinan, Shandong
    China

    Site Not Available

  • Linyi People's Hospital

    Linyi, Shandong
    China

    Site Not Available

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong
    China

    Site Not Available

  • Yantai Yuhuangding Hospital

    Yantai, Shandong
    China

    Site Not Available

  • Huashan Hospital Affiliated to Fudan University

    Shanghai, Shanghai
    China

    Site Not Available

  • Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai
    China

    Site Not Available

  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai
    China

    Site Not Available

  • First Hospital of Shanxi Medical University

    Taiyuan, Shanxi
    China

    Site Not Available

  • Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi
    China

    Site Not Available

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi
    China

    Site Not Available

  • Shanxi Provincial People's Hospital

    Taiyuan, Shanxi
    China

    Site Not Available

  • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

    Chengdu, Sichuan
    China

    Site Not Available

  • West China Hospital of Sichuan University

    Chengdu, Sichuan
    China

    Site Not Available

  • The Second People's Hospital of Yibin

    Yibin, Sichuan
    China

    Site Not Available

  • The Second Hospital of Tianjin Medical University

    Tianjin, Tianjin
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin
    China

    Site Not Available

  • People's Hospital of Xinjiang Uygur Autonomous Region

    Urumqi, Xinjiang Uygur Autonomous Region
    China

    Site Not Available

  • The First Affiliated Hospital of Xinjiang Medical University

    Urumqi, Xinjiang Uygur Autonomous Region
    China

    Site Not Available

  • The First People's Hospital of Yunnan Province

    Kunming, Yunnan
    China

    Site Not Available

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang
    China

    Site Not Available

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang
    China

    Site Not Available

  • Jinhua Municipal Central Hospital

    Jinhua, Zhejiang
    China

    Site Not Available

  • Ningbo First Hospital

    Ningbo, Zhejiang
    China

    Site Not Available

  • Ningbo Huamei Hospital, University of Chinese Academy of Sciences

    Ningbo, Zhejiang
    China

    Site Not Available

  • Ningbo No.2 Hospital

    Ningbo, Zhejiang
    China

    Site Not Available

  • Ningbo Traditional Chinese Medicine Hospital

    Ningbo, Zhejiang
    China

    Site Not Available

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang
    China

    Site Not Available

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang
    China

    Site Not Available

  • Wenzhou Central Hospital

    Wenzhou, Zhejiang
    China

    Site Not Available

  • Wenzhou People's Hospital

    Wenzhou, Zhejiang
    China

    Site Not Available

  • Tongde Hospital of Zhejing Province

    Hangzhou, Zhejing
    China

    Site Not Available

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