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Active, not recruitingNCT05799287Updated Dec 16, 2025

A Study of Telitacicept for IgA Nephropathy (TELIGAN)

A Phase 3 interventional study of Telitacicept and Placebo in Primary IgA Nephropathy, sponsored by RemeGen Co., Ltd.. Active, not recruiting at 101 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-16.

Sponsored by RemeGen Co., Ltd. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as active, not recruiting.
Phase
Phase 3
Study type
Interventional
Enrollment
318
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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).

Read the 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.

02

Conditions studied

  • Primary IgA Nephropathy

Keywords

  • Autoimmune Diseases
  • Immune System Diseases
  • IgA Nephropathy
03

In context

Glomerulonephritis, IGA

254 studies on the registry are indexed under Glomerulonephritis, IGA; 100 are open to participants now.

This study's enrollment of 318 is above the median of 70 across 206 interventional studies indexed under Glomerulonephritis, IGA.

Browse Glomerulonephritis, IGA studies →

Lead sponsor

RemeGen Co., Ltd. is the lead sponsor of 77 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
318 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • BiologicalTelitacicept

    Subcutaneous injection

    Also known as: RC18

  • DrugPlacebo

    Placebo to Telitacicept

06

What researchers measure

Primary outcomes

  1. Change from baseline in urine protein creatinine ratio (UPCR)

    Based on a 24-hour urine collections.

    Time frame: 39 weeks

  2. Annualized estimated glomerular filtration rate (eGFR) slope

    eGFR is calculated using the CKD-EPI formula.

    Time frame: 104 weeks

Secondary outcomes

  1. Proportion of patients with a 30% decrease in estimated glomerular filtration rate (eGFR) compared with baseline

    eGFR is calculated using the CKD-EPI formula.

    Time frame: 39 weeks

  2. 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.

    Time frame: up to 104 weeks

  3. 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.

    Time frame: up to 104 weeks

  4. Proportion of patients received rescue treatment.

    patients using systemic immunosuppressive medications, glucocorticoids (GCSs), etc.

    Time frame: up to 104 weeks

  5. 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.

    Time frame: up to 104 weeks

  6. Change from baseline in urine protein creatinine ratio (UPCR)

    Based on 24-hour urine collections.

    Time frame: 52 weeks,78 weeks,104 weeks

  7. Change from baseline in estimated glomerular filtration rate (eGFR)

    eGFR is calculated using the CKD-EPI formula.

    Time frame: 39 weeks, 52 weeks,78 weeks,104 weeks

  8. Change from baseline in UACR in urine albumin-to-creatinine ratio (UACR)

    Based on 24-hour urine collections.

    Time frame: 39 weeks, 52 weeks,78 weeks,104 weeks

  9. 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).

    Time frame: up to 104 weeks

  10. Proportion of patients achieving urine protein creatinine ratio (UPCR) < 0.8 g/g

    UPCR is calculated based on 24-hour urine collections;

    Time frame: 39 weeks, 52 weeks,78 weeks,104 weeks

  11. Annualized estimated glomerular filtration rate (eGFR) slope

    eGFR is calculated using the CKD-EPI formula.

    Time frame: 52 weeks

Other outcomes

  1. Change from baseline in 24-hour urine protein

    based on 24-hour urine collections

    Time frame: 39 weeks

07

Study locations

101 sites
  • The First Affiliated Hospital of Bengbu Medical University
    Bengbu, Anhui, China
  • The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
    Hefei, Anhui, China
  • The Second Hospital of Anhui Medical University
    Hefei, Anhui, China
  • The First Affiliated Hospital of Wannan Medical College
    Wuhu, Anhui, 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
  • Peking University First Hospital
    Beijing, Beijing Municipality, China
  • Peking University People's Hospital
    Beijing, Beijing Municipality, China
  • Peking University Shougang Hospital
    Beijing, Beijing Municipality, China
  • The First Affiliated Hospital of Army Medical University
    Chongqing, Chongqing Municipality, China
  • The Second Affiliated Hospital of Chongqing Medical University
    Chongqing, Chongqing Municipality, China
  • The First Affiliated Hospital of Xiamen University
    Xiamen, Fujian, China
  • Zhongshan Hospital Xiamen University
    Xiamen, Fujian, China
  • Gansu Provincial Hospital
    Lanzhou, Gansu, China
  • Lanzhou University Second Hospital
    Lanzhou, Gansu, China
  • The First Hospital of Lanzhou University
    Lanzhou, Gansu, China
  • Guangdong Provincial People's Hospital
    Guangzhou, Guangdong, China
  • The Second Affiliated Hospital of Guangzhou Medical University
    Guangzhou, Guangdong, China
  • The Third Affiliated Hospital of Southern Medical University
    Guangzhou, Guangdong, China
  • Zhujiang Hospital of Southern Medical University
    Guangzhou, Guangdong, China
  • Shantou Central Hospital
    Shantou, Guangdong, China
  • Longgang District People's Hospital of Shenzhen
    Shenzhen, Guangdong, China
  • Peking University Shenzhen Hospital
    Shenzhen, Guangdong, China
  • Shenzhen Hospital of Southern Medical University
    Shenzhen, Guangdong, China
  • Shenzhen People's Hospital
    Shenzhen, Guangdong, China
  • Affiliated Hospital of Guangdong Medical University
    Zhanjiang, Guangdong, China
  • Zhuhai People's Hospital
    Zhuhai, Guangdong, China
  • The First Affiliated Hospital of Guilin Medical University
    Guilin, Guangxi, China
  • Liuzhou Workers' Hospital
    Liuzhou, Guangxi, China
  • The First Affiliated Hospital of Guangxi Medical University
    Nanning, Guangxi, China
  • Guizhou Provincial People's Hospital
    Guiyang, Guizhou, China
  • Affiliated Hospital of Zunyi Medical University
    Zunyi, Guizhou, China
  • Affiliated Hospital of Hebei University
    Baoding, Hebei, China
  • Cangzhou Central Hospital
    Cangzhou, Hebei, China
  • Handan First Hospital
    Handan, Hebei, China
  • First Hospital of Qinhuangdao
    Qinhuangdao, Hebei, China
  • The Second Hospital of Hebei Medical University
    Shijiazhuang, Hebei, China
  • Xingtai People's Hospital
    Xingtai, Hebei, 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
  • Nanyang Central Hospital
    Nanyang, Henan, China
  • Henan Provincial People's Hospital
    Zhengzhou, Henan, China
  • The First Affiliated Hospital of Zhengzhou University
    Zhengzhou, Henan, China
  • Renmin Hospital of Wuhan University
    Wuhan, Hubei, China
  • Zhongnan Hospital of Wuhan University
    Wuhan, Hubei, 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
    Changsha, Hunan, China
  • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
    Baotou, Inner Mongolia, China
  • The Affiliated Hospital of Inner Mongolia Medical University
    Hohhot, Inner Mongolia, China
  • Changzhou No.2 People's Hospital
    Changzhou, Jiangsu, China
  • Jiangsu Provincial People's Hospital
    Nanjing, Jiangsu, China
  • Zhongda Hospital Southeast University
    Nanjing, Jiangsu, China
  • Wuxi People's Hospital
    Wuxi, Jiangsu, China
  • The Affiliated Hospital of Xuzhou Medical University
    Xuzhou, Jiangsu, China
  • Jiangxi Provincial People's Hospital
    Nanchang, Jiangxi, China
  • The First Affiliated Hospital of Nanchang University
    Nanchang, Jiangxi, China
  • The Second Affiliated Hospital of Nanchang University
    Nanchang, Jiangxi, China
  • China-Japan Union Hospital of Jilin University
    Changchun, Jilin, China
  • Jilin Province People's Hospital
    Changchun, Jilin, China
  • The First Hospital of Jilin University
    Changchun, Jilin, China
  • The Second Hospital of Jilin University
    Changchun, Jilin, China
  • General Hospital of Northern Theatre Command
    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 Ningxia Medical University
    Yinchuan, Ningxia, China
  • The First Affiliated Hospital of Xi'an Jiaotong University
    Xi'an, Shaanxi, China
  • The Second Affiliated Hospital of Xi'an Jiaotong University
    Xi'an, Shaanxi, China
  • Qilu Hospital of Shandong University
    Jinan, Shandong, China
  • Shandong Provincial Hospital
    Jinan, Shandong, China
  • Shandong Provincial Qianfoshan Hospital
    Jinan, Shandong, China
  • Linyi People's Hospital
    Linyi, Shandong, China
  • The Affiliated Hospital of Qingdao University
    Qingdao, Shandong, China
  • Yantai Yuhuangding Hospital
    Yantai, Shandong, 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
    Shanghai, Shanghai Municipality, China
  • First Hospital of Shanxi Medical University
    Taiyuan, Shanxi, China
  • Second Hospital of Shanxi Medical University
    Taiyuan, Shanxi, China
  • Shanxi Bethune Hospital
    Taiyuan, Shanxi, China
  • Shanxi Provincial People's Hospital
    Taiyuan, Shanxi, China
  • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
    Chengdu, Sichuan, China
  • West China Hospital of Sichuan University
    Chengdu, Sichuan, China
  • The Second People's Hospital of Yibin
    Yibin, Sichuan, China
  • The Second Hospital of Tianjin Medical University
    Tianjin, Tianjin Municipality, China
  • Tianjin Medical University General Hospital
    Tianjin, Tianjin Municipality, China
  • People's Hospital of Xinjiang Uygur Autonomous Region
    Ürümqi, Xinjiang Uygur Autonomous Region, China
  • The First Affiliated Hospital of Xinjiang Medical University
    Ürümqi, Xinjiang Uygur Autonomous Region, China
  • The First People's Hospital of Yunnan Province
    Kunming, Yunnan, China
  • The First Affiliated Hospital, Zhejiang University School of Medicine
    Hangzhou, Zhejiang, China
  • Zhejiang Provincial People's Hospital
    Hangzhou, Zhejiang, China
  • Jinhua Municipal Central Hospital
    Jinhua, Zhejiang, China
  • Ningbo Municipal Hospital of Traditional Chinese Medicine
    Ningbo, Zhejiang, China
  • Ningbo No.2 Hospital
    Ningbo, Zhejiang, China
  • The First Affiliated Hospital of Ningbo University
    Ningbo, Zhejiang, China
  • Taizhou Hospital of Zhejiang Province
    Taizhou, Zhejiang, China
  • First Affiliated Hospital of Wenzhou Medical University
    Wenzhou, Zhejiang, China
  • Wenzhou Central Hospital
    Wenzhou, Zhejiang, China
  • Wenzhou People's Hospital
    Wenzhou, Zhejiang, China

Showing the first 100 of 101 sites.

08

References and documents

Publications

  • Lv J, Liu L, Wang W, Wang X, Zuraw Q, Perkovic V, Fang J, Zhang H; TELIGAN Investigators. Telitacicept for IgA Nephropathy - Interim Analysis of a Phase 3 Trial. N Engl J Med. 2026 May 14;394(19):1916-1924. doi: 10.1056/NEJMoa2514415. PubMed 42127391 ↗
  • 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. PubMed 38299639 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05799287
Lead sponsor
RemeGen Co., Ltd.
Responsible party
Sponsor
First posted
Apr 5, 2023
Start date
Apr 28, 2023
Primary completion
Jun 2026 (estimated)
Completion
Jun 2026 (estimated)
Last update
Dec 16, 2025

Study contacts

Jicheng Lv, M.D.
principal investigator · Peking University First Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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