Primary IgA Nephropathy
Conditions
Brief summary
The study is being conducted to evaluate the efficacy, and safety of SHR - 2010 injection in patients with primary IgA nephropathy.
Interventions
SHR-2010 Injection
DRUGPlacebo
Placebo
Sponsors
Guangdong Hengrui Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: change from baseline in Urine Protein to Creatinine Ratio (UPCR) at 12weeks. | 12 weeks |
| Part 2: change from baseline in UPCR at 24weeks. | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| change from baseline in urinary albumin creatinine ratio (UACR) at 12weeks（Part 1） | 12 weeks |
| change from baseline in urinary albumin creatinine ratio (UACR) at 24weeks（Part 2）. | 24 weeks |
| change from baseline in 24 hours urinary protein at 12 weeks (part 1) | 12 weeks |
| change from baseline in glomerular filtration rate (eGFR) at 24weeks and 36weeks （Part 2）. | 24, 36 weeks |
| 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 24 weeks (part 2) | 24 weeks |
Countries
China
Outcome results
None listed