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

Phase 2

Terminated

• Conditions: Primary IgA Nephropathy
• Interventions: Drug: SHR-2010 Injection; Drug: Placebo

• Registration Number: NCT05847920
• Lead Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-27
• Study First Submitted QC: 2023-04-27
• Study First Posted: 2023-05-08
• Study Start: 2023-06-04
• Primary Completion: 2025-01-20
• Study Completion: 2025-01-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-03-02
• Last Update Posted: 2025-03-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHR-2010 Injection	SHR-2010 Injection	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Part 2: change from baseline in UPCR at 24weeks.	24 weeks
Part 1: change from baseline in Urine Protein to Creatinine Ratio (UPCR) at 12weeks.	12 weeks

Secondary Outcome Measures

Name	Time	Method
change from baseline in glomerular filtration rate (eGFR) at 12weeks and 24weeks （Part 1）.	12, 24 weeks
change from baseline in 24 hours urinary protein at 12 weeks (part 1)	12 weeks
change from baseline in 24 hours urinary protein at 24 weeks (part 2)	24 weeks
change from baseline in urinary albumin creatinine ratio (UACR) at 24weeks（Part 2）.	24 weeks
change from baseline in glomerular filtration rate (eGFR) at 24weeks and 36weeks （Part 2）.	24, 36 weeks
change from baseline in urinary albumin creatinine ratio (UACR) at 12weeks（Part 1）	12 weeks

Trial Locations

Locations (1)

General Hospital of Eastern Theater Command; 🇨🇳 Nanjing, Jiangsu, China