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Primary IgA NephropathyPhase 3NCT05799287

A Study of Telitacicept for IgA Nephropathy (TELIGAN)

A Phase 3 study testing Telitacicept in people with Primary IgA Nephropathy, run by RemeGen Co., Ltd. at 101 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Primary IgA Nephropathy
What is being tested?
Telitacicept
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
318 participants
Where
101 sitesChina
Study dates
28 Apr 2023to Jun 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntary informed consent provided;
  • Male or female aged ≥ 18 years old;
  • IgA nephropathy confirmed by pathological biopsy;
  • 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;
  • 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.

Who cannot join

  • Subjects with abnormal laboratory tests, including but not limited to the following:
  • White blood cell count < 1.5×109/L
  • Neutrophils < 1.0×109/L
  • Hemoglobin < 85.0 g/L
  • Platelet count < 80.0×109/L
  • Total bilirubin >2×ULN
Show all 33Show fewer
  • ALT>3×ULN
  • AST>3×ULN
  • Alkaline phosphatase>2×ULN
  • Creatine kinase>5×ULN
  • IgA<10 mg/dL; or IgG≤400mg/dL；
  • Patients with secondary IgA nephropathy, including but not limited to: Henoch-Schonlein purpura, ankylosing spondylitis, systemic lupus erythematosus, etc.;
  • 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 position SBP>140 mmHg or DBP>90 mmHg for at least once at 2 visits during the screening period;
  • Patients with poorly controlled type 1 and type 2 diabetes (glycated hemoglobin A1c[HbA1c] > 8% or 64mmol/mol);
  • Treatment with immunosuppressants within 12 weeks prior to randomization, including but not limited to cyclophosphamide, azathioprine, mycophenolate, leflunomide, tacrolimus, cyclosporine, Tripterygium wilfordii;
  • Treatment with anti-CD20 therapy (for example, Rituximb Injection) within 24 weeks prior to randomization;
  • 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;
  • Had hospitalization or intravenous anti-infective therapy for active infection within 4 weeks prior to randomization;
  • Patients with active tuberculosis;
  • 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;
  • Patients with hepatitis C;
  • Patients with HIV infection;
  • 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;
  • Allergic to biological products of human origin;
  • 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;
  • Received live vaccination within 4 weeks prior to randomization;
  • Drug or alcohol abuse/dependence within 52 weeks prior to randomization;
  • Other circumstances that, in the opinion of the investigator, are not suitable for participation in this study.

Trial locations and contacts

101 sites in 1 country.

101 sites in 1 country

China101 sites

  • Affiliated Hospital of Hebei University

    Baoding, Hebei

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

    Baotou, Inner Mongolia

  • Beijing Anzhen Hospital Affiliated to Capital Medical University

    Beijing, Beijing Municipality

  • Beijing Hospital

    Beijing, Beijing Municipality

  • Beijing Tsinghua Changgung Hospital

    Beijing, Beijing Municipality

  • Peking University First Hospital

    Beijing, Beijing Municipality

  • Peking University People's Hospital

    Beijing, Beijing Municipality

  • Peking University Shougang Hospital

    Beijing, Beijing Municipality

  • The First Affiliated Hospital of Bengbu Medical University

    Bengbu, Anhui

  • Cangzhou Central Hospital

    Cangzhou, Hebei

  • China-Japan Union Hospital of Jilin University

    Changchun, Jilin

  • Jilin Province People's Hospital

    Changchun, Jilin

  • The First Hospital of Jilin University

    Changchun, Jilin

  • The Second Hospital of Jilin University

    Changchun, Jilin

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan

  • Xiangya Hospital of Central South University

    Changsha, Hunan

  • Changzhou No.2 People's Hospital

    Changzhou, Jiangsu

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

    Chengdu, Sichuan

  • West China Hospital of Sichuan University

    Chengdu, Sichuan

  • The First Affiliated Hospital of Army Medical University

    Chongqing, Chongqing Municipality

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong

  • The Third Affiliated Hospital of Southern Medical University

    Guangzhou, Guangdong

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong

  • The First Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi

  • Guizhou Provincial People's Hospital

    Guiyang, Guizhou

  • Handan First Hospital

    Handan, Hebei

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang

  • Tongde Hospital of Zhejing Province

    Hangzhou, Zhejing

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

    Hefei, Anhui

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia

  • Qilu Hospital of Shandong University

    Jinan, Shandong

  • Shandong Provincial Hospital

    Jinan, Shandong

  • Shandong Provincial Qianfoshan Hospital

    Jinan, Shandong

  • Jinhua Municipal Central Hospital

    Jinhua, Zhejiang

  • The First People's Hospital of Yunnan Province

    Kunming, Yunnan

  • Gansu Provincial Hospital

    Lanzhou, Gansu

  • Lanzhou University Second Hospital

    Lanzhou, Gansu

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu

  • Linyi People's Hospital

    Linyi, Shandong

  • Liuzhou Workers' Hospital

    Liuzhou, Guangxi

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

    Luoyang, Henan

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

  • Jiangsu Provincial People's Hospital

    Nanjing, Jiangsu

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi

  • Nanyang Central Hospital

    Nanyang, Henan

  • Ningbo Municipal Hospital of Traditional Chinese Medicine

    Ningbo, Zhejiang

  • Ningbo No.2 Hospital

    Ningbo, Zhejiang

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong

  • First Hospital of Qinhuangdao

    Qinhuangdao, Hebei

  • Huashan Hospital，Fudan University

    Shanghai, Shanghai Municipality

  • Renji Hospital，Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality

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

    Shanghai, Shanghai Municipality

  • Shantou Central Hospital

    Shantou, Guangdong

  • General Hospital of Northern Theatre Command

    Shenyang, Liaoning

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning

  • The Affiliated Central Hospital of Shenyang Medical College

    Shenyang, Liaoning

  • Longgang District People's Hospital of Shenzhen

    Shenzhen, Guangdong

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong

  • Shenzhen Hospital of Southern Medical University

    Shenzhen, Guangdong

  • Shenzhen People's Hospital

    Shenzhen, Guangdong

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • First Hospital of Shanxi Medical University

    Taiyuan, Shanxi

  • Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi

  • Shanxi Provincial People's Hospital

    Taiyuan, Shanxi

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang

  • The Second Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality

  • People's Hospital of Xinjiang Uygur Autonomous Region

    Ürümqi, Xinjiang Uygur Autonomous Region

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang Uygur Autonomous Region

  • First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

  • Wenzhou Central Hospital

    Wenzhou, Zhejiang

  • Wenzhou People's Hospital

    Wenzhou, Zhejiang

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei

  • The First Affiliated Hospital of Wannan Medical College

    Wuhu, Anhui

  • Wuxi People's Hospital

    Wuxi, Jiangsu

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian

  • Zhongshan Hospital Xiamen University

    Xiamen, Fujian

  • Xingtai People's Hospital

    Xingtai, Hebei

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu

  • Yantai Yuhuangding Hospital

    Yantai, Shandong

  • The Second People's Hospital of Yibin

    Yibin, Sichuan

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia

  • The First Affiliated Hospital of Hebei North University

    Zhangjiakou, Hebei

  • Affiliated Hospital of Guangdong Medical University

    Zhanjiang, Guangdong

  • Henan Provincial People's Hospital

    Zhengzhou, Henan

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

  • Zhuhai People's Hospital

    Zhuhai, Guangdong

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, Guizhou

Other trials in China

About this study

Official title: 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).

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.

Being tested
Telitacicept, Placebo
Keywords
Autoimmune Diseases, Immune System Diseases, IgA Nephropathy
Medical subject headings
Glomerulonephritis, IGA, Autoimmune Diseases, Immune System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TelitaciceptBiological

    Also called RC18

    Subcutaneous injection

  • PlaceboDrug

    Placebo to Telitacicept

Study groups in NCT05799287
Study groupRoleWhat they receive
TelitaciceptExperimentalSubjects 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.
Receives: Biological: Telitacicept
PlaceboPlacebo comparatorSubjects 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Based on a 24-hour urine collections.

    Measured: 39 weeks

  2. Annualized estimated glomerular filtration rate (eGFR) slope

    eGFR is calculated using the CKD-EPI formula.

    Measured: 104 weeks

Secondary outcomes (11)

  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.

    Measured: 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.

    Measured: 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.

    Measured: up to 104 weeks

  4. Proportion of patients received rescue treatment.

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

    Measured: 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.

    Measured: up to 104 weeks

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

    Based on 24-hour urine collections.

    Measured: 52 weeks,78 weeks,104 weeks

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

    eGFR is calculated using the CKD-EPI formula.

    Measured: 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.

    Measured: 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).

    Measured: 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;

    Measured: 39 weeks, 52 weeks,78 weeks,104 weeks

  11. Annualized estimated glomerular filtration rate (eGFR) slope

    eGFR is calculated using the CKD-EPI formula.

    Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2023
  2. Study start28 Apr 2023
  3. Primary completionJun 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
318 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05799287
Sponsor's protocol ID
18C021
Status last verified
Dec 2025
First submitted
5 Mar 2023
Last updated
16 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Telitacicept in people with Primary IgA Nephropathy, run by RemeGen Co., Ltd. at 101 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 101 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in urine protein creatinine ratio (UPCR) (time frame: 39 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05799287, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.

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