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

Primary IgA Nephropathy Clinical Trial

Official title:

A Phase II Seamless Design, Randomized, Double-blind, Placebo-controlled, Dose-exploration Study Evaluate the Efficacy and Safety of SHR-2010 Injection in Patients With Primary IgA Nephropathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05847920
• Other study ID #: SHR-2010-201
• Status: Recruiting
• Phase: Phase 2
• Start date: June 4, 2023
• Est. completion date: April 30, 2026

Study information

• Verified date: April 2023
• Source: Guangdong Hengrui Pharmaceutical Co., Ltd
• Contact: Fei Gu
• Phone: 17721288037
• Email: fei.gu[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: April 30, 2026
• Est. primary completion date: January 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• Kidney Diseases
• Primary IgA Nephropathy

Intervention

Drug:
• SHR-2010 Injection
SHR-2010 Injection
• Placebo
Placebo

Locations

Country	Name	City	State
China	General Hospital of Eastern Theater Command	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Hengrui Pharmaceutical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1: change from baseline in Urine Protein to Creatinine Ratio (UPCR) at 12weeks.		12 weeks
Primary	Part 2: change from baseline in UPCR at 24weeks.		24 weeks
Secondary	change from baseline in 24 hours urinary protein at 12 weeks (part 1)		12 weeks
Secondary	change from baseline in 24 hours urinary protein at 24 weeks (part 2)		24 weeks
Secondary	change from baseline in urinary albumin creatinine ratio (UACR) at 12weeks(Part 1)		12 weeks
Secondary	change from baseline in urinary albumin creatinine ratio (UACR) at 24weeks(Part 2).		24 weeks
Secondary	change from baseline in glomerular filtration rate (eGFR) at 12weeks and 24weeks (Part 1).		12, 24 weeks
Secondary	change from baseline in glomerular filtration rate (eGFR) at 24weeks and 36weeks (Part 2).		24, 36 weeks