TerminatedPhase 2

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

Stopped: Based on the adjustment of the R \& D strategy, the sponsor decides to terminate the research.

China53 participantsStarted 2023-06-04

Plain-language summary

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

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Able and willing to provide a written informed consent
✓. Renal biopsy confirmed primary IgA nephropathy
✓. 24 hours urinary protein quantity ≥1g, or UPCR≥0.8 g/g
✓. eGFR≥30 mL/min/ 1.73m2
✓. 40kg≤ Weight ≤100kg
✓. Has been treated with optimized supportive treatment. (ACEI or ARB to maximum recommended dose or maximum tolerated dose).

✕. systemic disease which may cause secondary IgA deposition in the mesangial region
✕. Specific type of IgA nephropathy
✕. History of severe opportunistic infection
✕. A history of chronic or recurrent infection within 1 year prior to screening
✕. History of active digestive system within one year
✕. Have a malignant tumor or a history of malignant tumor
✕. Subjects who have received organ transplants
✕. Associated with other serious or poorly controlled systemic diseases

Part 1: change from baseline in Urine Protein to Creatinine Ratio (UPCR) at 12weeks.

Timeframe: 12 weeks

Part 2: change from baseline in UPCR at 24weeks.

Timeframe: 24 weeks

NCT IDNCT05847920

SponsorGuangdong Hengrui Pharmaceutical Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-01-20