A Study of Telitacicept in Patients With Primary IgA Nephropathy

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of Telitacicept in patients with primary IgA nephropathy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RemeGen Co., Ltd.

Criteria

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 ≥ 0.5 g/g 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 clinically significant abnormal laboratory tests;

2. Patients with secondary IgA nephropathy;

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 office SBP>140 mmHg or DBP>90 mmHg during the screening period;

8. HbA1c>8% (64mmol/mol);

9. Treatment with immunosuppressants (cyclophosphamide, azathioprine, mycophenolate, leflunomide, tacrolimus, cyclosporine, Tripterygium wilfordii, etc.) within 12 weeks prior to randomization;

10. Treatment with anti-CD20 therapy within 24 weeks prior to randomization;

11. Treatment with systemic glucocorticoid within 12 weeks prior to randomization;

12. Hospitalization or intravenous anti-infective therapy for active infection within 4 weeks prior to randomization;

13. Patients with active tuberculosis and untreated latent tuberculosis;

14. Hepatitis B: patients with active hepatitis (patients with positive HBsAg) or latent hepatitis B (patients with positive HBcAb and positive HBV-DNA);

15. Patients with hepatitis C;

16. Patients with HIV;

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. Unavoidable use of drugs with renal toxicity during the study;

20. Allergic to biological products of human origin;

21. Patients who have received any investigational therapy within 4 weeks or within 5 times the half-life of the investigational product (whichever is longer) prior to randomization;

22. Live vaccination within 4 weeks prior to randomization;

23. Patients with COVID-19 infection within 4 weeks of randomization or patients with a history of serious COVID-19 disease requiring hospitalization within 52 weeks prior to screening;

24. Drug or alcohol abuse/dependence within 52 weeks prior to randomization;

25. Not suitable for the study in the opinion of the investigator.