Efficacy and Safety of SHR-2010 Injection in the Treatment of Primary IgA Nephropathy

• Status: Not yet recruiting
• Trial end date: 2026-04-30
• Target enrollment: 0
• Participant gender: All

Summary

The study is being conducted to evaluate the efficacy, and safety of SHR - 2010 injection in patients with primary IgA nephropathy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

Criteria

Inclusion Criteria:

1. Able and willing to provide a written informed consent

2. Renal biopsy confirmed primary IgA nephropathy

3. 24 hours urinary protein quantity ≥1g, or UPCR≥0.8 g/g

4. eGFR≥30 mL/min/ 1.73m2

5. 40kg≤ Weight ≤100kg

6. Has been treated with optimized supportive treatment. (ACEI or ARB to maximum recommended dose or maximum tolerated dose).

Exclusion Criteria:

1. systemic disease which may cause secondary IgA deposition in the mesangial region

2. Specific type of IgA nephropathy

3. History of severe opportunistic infection

4. A history of chronic or recurrent infection within 1 year prior to screening

5. History of active digestive system within one year

6. Have a malignant tumor or a history of malignant tumor

7. Subjects who have received organ transplants

8. Associated with other serious or poorly controlled systemic diseases

9. Hepatitis, syphilis, human immunodeficiency virus (HIV) infection

10. Received systemic immunosuppressive drugs other than glucocorticoids 8 weeks before screening or during run-in period.

11. Received any systemic glucocorticoid 8 weeks before screening or during run-in period