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

Hengrui Medicine

Status and phase: Terminated; Phase 2

Conditions: Primary IgA Nephropathy

Treatments: Drug: Placebo; Drug: SHR-2010 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT05847920

SHR-2010-201

Details and patient eligibility

About

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

Enrollment: 53 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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53 participants in 2 patient groups, including a placebo group

SHR-2010 Injection

Experimental group

Treatment:

Drug: SHR-2010 Injection

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo