This study will evaluate the efficacy and safety of HS-10390 in subjects with primary IgA nephropathy, and explore the optimal dose for the treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
HS-10390 will be administered daily
Irbesartan will be administered daily as a 150-mg oral tablet. For patients who tolerate the initial dose of 150 mg after 2 weeks will increase their dose to 300 mg
Peking University First Hospital
Beijing, China
Change from baseline in 24-hour urine protein at Week 12
The change in urine protein: creatinine ratio (UPCR) from baseline to Week 12
Time frame: up to week 12
Change from baseline in 24-hour urine protein (UPCR)
The change in urine protein: creatinine ratio (UPCR) from baseline
Time frame: up to Week 12
Change from baseline in 24-hour urine protein(UACR)
The change in urine albumin: creatinine ratio (UACR) from baseline
Time frame: up to Week 12
Change from baseline in 24-hour urine protein
The change in urine protein excretion from baseline
Time frame: up to Week 12
Proportion Change from baseline in 24-hour urine protein
The proportion of patients with urinary protein equivalent of \< 0.3 g/24 hours
Time frame: up to Week 12
change from baseline in Estimated Glomerular Filtration Rate
change from baseline in Estimated Glomerular Filtration Rate (eGFR)
Time frame: up to Week 12
Number of subjects with adverse events (AEs)
Type, incidence, severity, seriousness, and relatedness of AEs will be collected
Time frame: up to Week 12
Plasma Concentration of HS-10390
Blood samples will be collected for the measurement of plasma concentrations of HS-10390
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Time frame: up to Week 12