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

Last updated: March 2, 2025
Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd
Overall Status: Terminated

Phase

2

Condition

Glomerulonephritis

Treatment

SHR-2010 Injection

Placebo

Clinical Study ID

NCT05847920
SHR-2010-201
  • Ages 18-70
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 maximumrecommended dose or maximum tolerated dose).

Exclusion

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 beforescreening or during run-in period.

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

Study Design

Total Participants: 53
Treatment Group(s): 2
Primary Treatment: SHR-2010 Injection
Phase: 2
Study Start date:
June 04, 2023
Estimated Completion Date:
January 20, 2025

Connect with a study center

  • General Hospital of Eastern Theater Command

    Nanjing, Jiangsu 210002
    China

    Site Not Available

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