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Active, not recruiting Phase 3

A Study of Telitacicept for IgA Nephropathy (TELIGAN)

NCT05799287 · tracked via the Priya Life Science Japan tracker
Phase
Phase 3
Started
2023-04-28
Last updated
2025-12-16

Condition(s) studied

Primary IgA Nephropathy

Investigational drug(s) / intervention(s)

Telitacicept →Placebo

Telitacicept: Subcutaneous injection

Placebo: Placebo to Telitacicept

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

Sex
ALL
Min age
18 Years
Max age
—
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: 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.

Primary outcome measure(s)

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

Trial sites (101)

FacilityCityRegionStatus
The First Affiliated Hospital of Bengbu Medical University Bengbu Anhui
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 First Affiliated Hospital of Wannan Medical College Wuhu Anhui
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 Army Medical University Chongqing Chongqing Municipality
The Second Affiliated Hospital of Chongqing Medical University Chongqing Chongqing Municipality
The First Affiliated Hospital of Xiamen University Xiamen Fujian
Zhongshan Hospital Xiamen University Xiamen Fujian
Gansu Provincial Hospital Lanzhou Gansu
Lanzhou University Second Hospital Lanzhou Gansu
The First Hospital of Lanzhou University Lanzhou Gansu
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
Shantou Central Hospital Shantou Guangdong
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
Affiliated Hospital of Guangdong Medical University Zhanjiang Guangdong
Zhuhai People's Hospital Zhuhai Guangdong
The First Affiliated Hospital of Guilin Medical University Guilin Guangxi
Liuzhou Workers' Hospital Liuzhou Guangxi
The First Affiliated Hospital of Guangxi Medical University Nanning Guangxi
Guizhou Provincial People's Hospital Guiyang Guizhou
Affiliated Hospital of Zunyi Medical University Zunyi Guizhou
Affiliated Hospital of Hebei University Baoding Hebei
Cangzhou Central Hospital Cangzhou Hebei
Handan First Hospital Handan Hebei
First Hospital of Qinhuangdao Qinhuangdao Hebei
The Second Hospital of Hebei Medical University Shijiazhuang Hebei
Xingtai People's Hospital Xingtai Hebei
The First Affiliated Hospital of Hebei North University Zhangjiakou Hebei

+ 61 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05799287 on ClinicalTrials.gov ↗ ← All trials in Japan