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ACTIVE NOT RECRUITING

NCT05799287

PHASE3

A Study of Telitacicept for IgA Nephropathy (TELIGAN)

Sponsor: RemeGen Co., Ltd.

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

318

Start Date

2023-04-28

Completion Date

2026-06

Last Updated

2025-12-16

Healthy Volunteers

Conditions

Primary IgA Nephropathy

Interventions

BIOLOGICAL

Telitacicept

Subcutaneous injection

DRUG

Placebo

Placebo to Telitacicept

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.

Locations (101)

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