New drug could slow kidney failure in IgA nephropathy patients

NCT ID NCT05799287

Disease control Sponsor: RemeGen Co., Ltd. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a drug called telitacicept in 318 adults with IgA nephropathy, a kidney disease that can lead to kidney failure. Participants are at high risk of worsening despite standard blood pressure medications. The goal is to see if telitacicept can reduce protein in the urine and slow the decline in kidney function over time.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

318 people

The number who actually took part.

Started

Apr 2023

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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/day based 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 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: 1. Subjects with abnormal laboratory tests, including but not limited to the following: 1. White blood cell count \< 1.5×109/L 2. Neutrophils \< 1.0×109/L 3. Hemoglobin \< 85.0 g/L 4. Platelet count \< 80.0×109/L 5. Total bilirubin \>2×ULN 6. ALT\>3×ULN 7. AST\>3×ULN 8. Alkaline phosphatase\>2×ULN 9. Creatine kinase\>5×ULN 10. IgA\<10 mg/dL; or IgG≤400mg/dL； 2. Patients with secondary IgA nephropathy, including but not limited to: Henoch-Schonlein purpura, ankylosing spondylitis, systemic lupus erythematosus, etc.; 3. Patients with other types of glomerular disease such as crescentic glomerulonephritis, minimal change nephropathy with IgA deposition;; 4. Renal transplant; 5. Patients with cirrhosis, as assessed by the investigator; 6. 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.; 7. Sitting position SBP\>140 mmHg or DBP\>90 mmHg for at least once at 2 visits during the screening period; 8. Patients with poorly controlled type 1 and type 2 diabetes (glycated hemoglobin A1c\[HbA1c\] \> 8% or 64mmol/mol); 9. Treatment with immunosuppressants within 12 weeks prior to randomization, including but not limited to cyclophosphamide, azathioprine, mycophenolate, leflunomide, tacrolimus, cyclosporine, Tripterygium wilfordii; 10. Treatment with anti-CD20 therapy (for example, Rituximb Injection) within 24 weeks prior to randomization; 11. Received systemic glucocorticoid treatment within 12 weeks prior to randomization, excluding the followings: ① received systemic treatment with prednisolone ≤ 0.5mg/kg or 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 nasal inhalation; 12. Had hospitalization or intravenous anti-infective therapy for active infection within 4 weeks prior to randomization; 13. Patients with active tuberculosis; 14. Hepatitis B: patients with active or latent hepatitis B (potive HBcAb and HBV-DNA); According to the test results of hepatitis B five items, subjects with positive HBsAg will be excluded; subjects who are HBsAg-negative but HBcAb-positive, whether HBsAb is positive or negative, should be tested for HBV-DNA: if HBV-DNA is positive, patients should be excluded; if HBV-DNA is negative, patients can participate in the trial, and subjects are advised to take oral entecavir for prophylactic antiviral therapy during the trial; 15. Patients with hepatitis C; 16. Patients with HIV infection; 17. 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; 18. Pregnant women, lactating women, and subjects with childbearing plans during the trial; 19. Allergic to biological products of human origin; 20. Participated in any clinical trial within 4 weeks or within 5 times the half-life of the investigational drug participating (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. Other circumstances that, in the opinion of the investigator, are not suitable for participation in this study.

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Conditions

The condition(s) this trial relates to.

autoimmune disease IgA glomerulonephritis immune system disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Primary IgA nephropathy

Contacts and locations

Locations

Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, China
Affiliated Hospital of Hebei University

Baoding, Hebei, China
Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China
Beijing Anzhen Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China
Beijing Hospital

Beijing, Beijing Municipality, China
Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, China
Cangzhou Central Hospital

Cangzhou, Hebei, China
Changzhou No.2 People's Hospital

Changzhou, Jiangsu, China
China-Japan Union Hospital of Jilin University

Changchun, Jilin, China
First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China
First Hospital of Qinhuangdao

Qinhuangdao, Hebei, China
First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China
Gansu Provincial Hospital

Lanzhou, Gansu, China
General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China
General Hospital of Northern Theatre Command

Shenyang, Liaoning, China
Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China
Guizhou Provincial People's Hospital

Guiyang, Guizhou, China
Handan First Hospital

Handan, Hebei, China
Henan Provincial People's Hospital

Zhengzhou, Henan, China
Huashan Hospital，Fudan University

Shanghai, Shanghai Municipality, China
Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China
Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, China
Jilin Province People's Hospital

Changchun, Jilin, China
Jinhua Municipal Central Hospital

Jinhua, Zhejiang, China
Lanzhou University Second Hospital

Lanzhou, Gansu, China
Linyi People's Hospital

Linyi, Shandong, China
Liuzhou Workers' Hospital

Liuzhou, Guangxi, China
Longgang District People's Hospital of Shenzhen

Shenzhen, Guangdong, China
Nanyang Central Hospital

Nanyang, Henan, China
Ningbo Municipal Hospital of Traditional Chinese Medicine

Ningbo, Zhejiang, China
Ningbo No.2 Hospital

Ningbo, Zhejiang, China
Peking University First Hospital

Beijing, Beijing Municipality, China
Peking University People's Hospital

Beijing, Beijing Municipality, China
Peking University Shenzhen Hospital

Shenzhen, Guangdong, China
Peking University Shougang Hospital

Beijing, Beijing Municipality, China
People's Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang Uygur Autonomous Region, China
Qilu Hospital of Shandong University

Jinan, Shandong, China
Renji Hospital，Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China
Renmin Hospital of Wuhan University

Wuhan, Hubei, China
Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, China
Shandong Provincial Hospital

Jinan, Shandong, China
Shandong Provincial Qianfoshan Hospital

Jinan, Shandong, China
Shantou Central Hospital

Shantou, Guangdong, China
Shanxi Bethune Hospital

Taiyuan, Shanxi, China
Shanxi Provincial People's Hospital

Taiyuan, Shanxi, China
Shengjing Hospital of China Medical University

Shenyang, Liaoning, China
Shenzhen Hospital of Southern Medical University

Shenzhen, Guangdong, China
Shenzhen People's Hospital

Shenzhen, Guangdong, China
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

Chengdu, Sichuan, China
Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China
The Affiliated Central Hospital of Shenyang Medical College

Shenyang, Liaoning, China
The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, China
The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China
The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China
The First Affiliated Hospital of Army Medical University

Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology

Baotou, Inner Mongolia, China
The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, China
The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China
The First Affiliated Hospital of Guilin Medical University

Guilin, Guangxi, China
The First Affiliated Hospital of Hebei North University

Zhangjiakou, Hebei, China
The First Affiliated Hospital of Henan University of science and Technology

Luoyang, Henan, China
The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China
The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)

Hefei, Anhui, China
The First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, China
The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China
The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China
The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang Uygur Autonomous Region, China
The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China
The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China
The First Hospital of Jilin University

Changchun, Jilin, China
The First Hospital of Lanzhou University

Lanzhou, Gansu, China
The First People's Hospital of Yunnan Province

Kunming, Yunnan, China
The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China
The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China
The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China
The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China
The Second Hospital of Anhui Medical University

Hefei, Anhui, China
The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China
The Second Hospital of Jilin University

Changchun, Jilin, China
The Second Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, China
The Second People's Hospital of Yibin

Yibin, Sichuan, China
The Second Xiangya Hospital of Central South University

Changsha, Hunan, China
The Third Affiliated Hospital of Southern Medical University

Guangzhou, Guangdong, China
The Third Xiangya Hospital of Central South University

Changsha, Hunan, China
Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China
Tongde Hospital of Zhejing Province

Hangzhou, Zhejing, China
Wenzhou Central Hospital

Wenzhou, Zhejiang, China
Wenzhou People's Hospital

Wenzhou, Zhejiang, China
West China Hospital of Sichuan University

Chengdu, Sichuan, China
Wuxi People's Hospital

Wuxi, Jiangsu, China
Xiangya Hospital of Central South University

Changsha, Hunan, China
Xingtai People's Hospital

Xingtai, Hebei, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China
Yantai Yuhuangding Hospital

Yantai, Shandong, China
Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China
Zhongda Hospital Southeast University

Nanjing, Jiangsu, China
Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China
Zhongshan Hospital Xiamen University

Xiamen, Fujian, China
Zhuhai People's Hospital

Zhuhai, Guangdong, China
Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

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