A Study of Telitacicept for IgA Nephropathy (TELIGAN)

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Primary IgA Nephropathy
• Intervention / Treatment: Drug: Placebo; Biological: Telitacicept

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 318
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China
      • The First Affiliated Hospital of Bengbu Medical University
    • Hefei, Anhui, China
      • The Second Hospital of Anhui Medical University
    • Hefei, Anhui, China
      • The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
    • Wuhu, Anhui, China
      • The First Affiliated Hospital of Wannan Medical College
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Beijing Tsinghua Changgung Hospital
    • Beijing, Beijing Municipality, China
      • Beijing Hospital
    • Beijing, Beijing Municipality, China
      • Peking University People's Hospital
    • Beijing, Beijing Municipality, China
      • Peking University First Hospital
    • Beijing, Beijing Municipality, China
      • Peking University Shougang Hospital
    • Beijing, Beijing Municipality, China
      • Beijing Anzhen Hospital Affiliated to Capital Medical University
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China
      • The First Affiliated Hospital of Army Medical University
    • Chongqing, Chongqing Municipality, China
      • The Second Affiliated Hospital of Chongqing Medical University
  • Fujian
    • Xiamen, Fujian, China
      • The first affiliated hospital of xiamen university
    • Xiamen, Fujian, China
      • Zhongshan Hospital Xiamen University
  • Gansu
    • Lanzhou, Gansu, China
      • The First Hospital of Lanzhou University
    • Lanzhou, Gansu, China
      • Lanzhou University Second Hospital
    • Lanzhou, Gansu, China
      • Gansu Provincial Hospital
  • Guangdong
    • Guangzhou, Guangdong, China
      • The Second Affiliated Hospital of Guangzhou Medical University
    • Guangzhou, Guangdong, China
      • Guangdong Provincial People's Hospital
    • Guangzhou, Guangdong, China
      • Zhujiang Hospital of Southern Medical University
    • Guangzhou, Guangdong, China
      • The Third Affiliated Hospital of Southern Medical University
    • Shantou, Guangdong, China
      • Shantou Central Hospital
    • Shenzhen, Guangdong, China
      • ShenZhen People's Hospital
    • Shenzhen, Guangdong, China
      • Peking University Shenzhen Hospital
    • Shenzhen, Guangdong, China
      • Shenzhen Hospital of Southern Medical University
    • Shenzhen, Guangdong, China
      • Longgang District People's Hospital of Shenzhen
    • Zhanjiang, Guangdong, China
      • Affiliated Hospital Of Guangdong Medical University
    • Zhuhai, Guangdong, China
      • Zhuhai People's Hospital
  • Guangxi
    • Guilin, Guangxi, China
      • The First Affiliated Hospital of Guilin Medical University
    • Liuchow, Guangxi, China
      • Liuzhou Workers' Hospital
    • Nanning, Guangxi, China
      • The First Affiliated Hospital of Guangxi Medical University
  • Guizhou
    • Guiyang, Guizhou, China
      • Guizhou Provincial People's Hospital
    • Zunyi, Guizhou, China
      • Affiliated Hospital of Zunyi Medical University
  • Hebei
    • Baoding, Hebei, China
      • Affiliated Hospital of Hebei University
    • Cangzhou, Hebei, China
      • Cangzhou Central Hospital
    • Handan, Hebei, China
      • Handan First Hospital
    • Qinhuangdao, Hebei, China
      • First Hospital of Qinhuangdao
    • Shijiazhuang, Hebei, China
      • The Second Hospital of Hebei Medical University
    • Xingtai, Hebei, China
      • Xingtai People's Hospital
    • Zhangjiakou, Hebei, China
      • The First Affiliated Hospital of Hebei North University
  • Henan
    • Luoyang, Henan, China
      • The First Affiliated Hospital of Henan University of Science And Technology
    • Nanyang, Henan, China
      • Nanyang Central Hospital
    • Zhengzhou, Henan, China
      • The first affiliated hospital of Zhengzhou university
    • Zhengzhou, Henan, China
      • Henan Provincial People's Hospital
  • Hubei
    • Wuhan, Hubei, China
      • Zhongnan Hospital of Wuhan University
    • Wuhan, Hubei, China
      • Renmin Hospital of Wuhan University
  • Hunan
    • Changsha, Hunan, China
      • The second Xiangya hospital of central south university
    • Changsha, Hunan, China
      • The Third Xiangya Hospital of Central South University
    • Changsha, Hunan, China
      • Xiangya Hospital of Central South University
  • Inner Mongolia
    • Baotou, Inner Mongolia, China
      • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
    • Hohhot, Inner Mongolia, China
      • The Affiliated Hospital of Inner Mongolia Medical University
  • Jiangsu
    • Changzhou, Jiangsu, China
      • Changzhou No.2 People's Hospital
    • Nanjing, Jiangsu, China
      • Zhongda Hospital Southeast University
    • Nanjing, Jiangsu, China
      • Jiangsu Provincial People's Hospital
    • Wuxi, Jiangsu, China
      • Wuxi People's Hospital
    • Xuzhou, Jiangsu, China
      • The Affiliated Hospital of Xuzhou Medical University
  • Jiangxi
    • Nanchang, Jiangxi, China
      • The Second Affiliated Hospital of Nanchang University
    • Nanchang, Jiangxi, China
      • The First Affiliated Hospital of NanChang University
    • Nanchang, Jiangxi, China
      • Jiangxi Provincial People's Hospital
  • Jilin
    • Changchun, Jilin, China
      • The First Hospital of Jilin University
    • Changchun, Jilin, China
      • The Second Hospital of Jilin University
    • Changchun, Jilin, China
      • Jilin Province People's Hospital
    • Changchun, Jilin, China
      • China-Japan Union Hospital of Jilin University
  • Liaoning
    • Shenyang, Liaoning, China
      • Shengjing Hospital Of China Medical University
    • Shenyang, Liaoning, China
      • The Affiliated Central Hospital of Shenyang Medical College
    • Shenyang, Liaoning, China
      • General Hospital of Northern Theatre Command
  • Ningxia
    • Yinchuan, Ningxia, China
      • General Hospital of Ningxia Medical University
  • Shaanxi
    • Xi'an, Shaanxi, China
      • The Second Affiliated Hospital of Xi'an Jiaotong University
    • Xi'an, Shaanxi, China
      • The First Affiliated Hospital of Xi'an Jiaotong University
  • Shandong
    • Jinan, Shandong, China
      • Qilu Hospital of Shandong University
    • Jinan, Shandong, China
      • Shandong Provincial Hospital
    • Jinan, Shandong, China
      • Shandong Provincial Qianfoshan Hospital
    • Linyi, Shandong, China
      • Linyi People's Hospital
    • Qingdao, Shandong, China
      • The Affiliated Hospital of Qingdao University
    • Yantai, Shandong, China
      • Yantai Yuhuangding Hospital
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Huashan Hospital,Fudan University
    • Shanghai, Shanghai Municipality, China
      • Renji Hospital,Shanghai Jiaotong University School of Medicine
    • Shanghai, Shanghai Municipality, China
      • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  • Shanxi
    • Taiyuan, Shanxi, China
      • First Hospital of Shanxi Medical University
    • Taiyuan, Shanxi, China
      • Shanxi Bethune Hospital
    • Taiyuan, Shanxi, China
      • Shanxi Provincial People's Hospital
    • Taiyuan, Shanxi, China
      • Second Hospital of Shanxi Medical University
  • Sichuan
    • Chengdu, Sichuan, China
      • West China Hospital of Sichuan University
    • Chengdu, Sichuan, China
      • Sichuan Academy of Medical Sciences ＆ Sichuan Provincial People's Hospital
    • Yibin, Sichuan, China
      • The Second People's Hospital of Yibin
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China
      • Tianjin Medical University General Hospital
    • Tianjin, Tianjin Municipality, China
      • The Second Hospital Of Tianjin Medical University
  • Xinjiang Uygur Autonomous Region
    • Ürümqi, Xinjiang Uygur Autonomous Region, China
      • People's Hospital of Xinjiang Uygur Autonomous Region
    • Ürümqi, Xinjiang Uygur Autonomous Region, China
      • The first affiliated hospital of Xinjiang medical university
  • Yunnan
    • Kunming, Yunnan, China
      • The First People's Hospital of Yunnan Province
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • The first Affiliated Hospital, Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China
      • Zhejiang Provincial People's Hospital
    • Jinhua, Zhejiang, China
      • Jinhua Municipal Central Hospital
    • Ningbo, Zhejiang, China
      • Ningbo No.2 Hospital
    • Ningbo, Zhejiang, China
      • The First Affiliated Hospital of Ningbo University
    • Ningbo, Zhejiang, China
      • Ningbo Municipal Hospital of Traditional Chinese Medicine
    • Taizhou, Zhejiang, China
      • Taizhou Hospital of Zhejiang Province
    • Wenzhou, Zhejiang, China
      • First Affiliated Hospital of Wenzhou Medical University
    • Wenzhou, Zhejiang, China
      • Wenzhou Central Hospital
    • Wenzhou, Zhejiang, China
      • Wenzhou People's Hospital
  • Zhejing
    • Hangzhou, Zhejing, China
      • Tongde Hospital of Zhejing Province

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Biological: Telitacicept; Subcutaneous injection; Other Names: RC18
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.	Drug: Placebo; Placebo to Telitacicept

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in urine protein creatinine ratio (UPCR)	Based on a 24-hour urine collections.	39 weeks
Annualized estimated glomerular filtration rate (eGFR) slope	eGFR is calculated using the CKD-EPI formula.	104 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of adverse events	An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.	up to 104 weeks
Proportion of patients with a 30% decrease in estimated glomerular filtration rate (eGFR) compared with baseline	eGFR is calculated using the CKD-EPI formula.	39 weeks
Time to 30% reduction from baseline in eGFR	eGFR is calculated using the CKD-EPI formula and confirmed by a second sample collection and calculation after at least 4 weeks.	up to 104 weeks
Proportion of patients with a 40% decrease in estimated glomerular filtration rate (eGFR) compared with baseline	eGFR is calculated using the CKD-EPI formula and confirmed by a second sample collection and calculation after at least 4 weeks.	up to 104 weeks
Proportion of patients received rescue treatment.	patients using systemic immunosuppressive medications, glucocorticoids (GCSs), etc.	up to 104 weeks
Change from baseline in urine protein creatinine ratio (UPCR)	Based on 24-hour urine collections.	52 weeks,78 weeks,104 weeks
Change from baseline in estimated glomerular filtration rate (eGFR)	eGFR is calculated using the CKD-EPI formula.	39 weeks, 52 weeks,78 weeks,104 weeks
Change from baseline in UACR in urine albumin-to-creatinine ratio (UACR)	Based on 24-hour urine collections.	39 weeks, 52 weeks,78 weeks,104 weeks
Time to composite endpoint event	The composite endpoint event is defined as initiation of maintenance renal dialysis (for at least 1 month), eGFR <15 mL/min/1.73 m^2, renal transplant, or death due to renal failure. eGFR is calculated using the CKD-EPI formula (CKD-EPI).	up to 104 weeks
Proportion of patients achieving urine protein creatinine ratio (UPCR) < 0.8 g/g	UPCR is calculated based on 24-hour urine collections;	39 weeks, 52 weeks,78 weeks,104 weeks
Annualized estimated glomerular filtration rate (eGFR) slope	eGFR is calculated using the CKD-EPI formula.	52 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in 24-hour urine protein	based on 24-hour urine collections	39 weeks

Collaborators and Investigators

• Sponsor: RemeGen Co., Ltd.
• Investigators: Principal Investigator: Jicheng Lv, M.D., Peking University First Hospital

Publications and helpful links

General Publications

• Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: March 5, 2023
• First Submitted That Met QC Criteria: March 22, 2023
• First Posted (Actual): April 5, 2023

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Immune System Diseases; Autoimmune Diseases; IgA Nephropathy
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Glomerulonephritis; Nephritis; Autoimmune Diseases; Glomerulonephritis, IGA; Immune System Diseases; telitacicept
• Other Study ID Numbers: 18C021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No