The study is being conducted to evaluate the efficacy, and safety of SHR - 2010 injection in patients with primary IgA nephropathy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
53
SHR-2010 Injection
Placebo
General Hospital of Eastern Theater Command
Nanjing, Jiangsu, China
Part 1: change from baseline in Urine Protein to Creatinine Ratio (UPCR) at 12weeks.
Time frame: 12 weeks
Part 2: change from baseline in UPCR at 24weeks.
Time frame: 24 weeks
change from baseline in 24 hours urinary protein at 12 weeks (part 1)
Time frame: 12 weeks
change from baseline in 24 hours urinary protein at 24 weeks (part 2)
Time frame: 24 weeks
change from baseline in urinary albumin creatinine ratio (UACR) at 12weeks(Part 1)
Time frame: 12 weeks
change from baseline in urinary albumin creatinine ratio (UACR) at 24weeks(Part 2).
Time frame: 24 weeks
change from baseline in glomerular filtration rate (eGFR) at 12weeks and 24weeks (Part 1).
Time frame: 12, 24 weeks
change from baseline in glomerular filtration rate (eGFR) at 24weeks and 36weeks (Part 2).
Time frame: 24, 36 weeks
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