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.
Male or female, between 18 and 65 years age.
Biopsy-proven primary IgA nephropathy.
Currently on stable dose of ACEI and/or ARB therapy, for at least 12 weeks prior to screening (the patient's maximum tolerated dose and is at least one-half of the maximum labeled dose).
Average 24-hour urine total protein ≥ 0.75 g/24 h at screening.
IgA nephropathy secondary to another condition
IgA nephropathy with rapid decline of renal function; Kidney pathology indicated that more than 50% of the glomerulus had large crescent body formation, which may affect the study results; Tubule atrophy - interstitial fibrosis of more than 50%;
Chronic kidney disease (CKD) in addition to IgAN
Patients treated with any systemic non-biologic immunosuppressive drugs (including systemic corticosteroids) within 12 weeks prior to randomizing；
Parallel
HS-10390
DrugHS-10390 will be administered daily
Irbesartan
DrugIrbesartan 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
Change from baseline in 24-hour urine protein at Week 12
The change in urine protein: creatinine ratio (UPCR) from baseline to Week 12
Change from baseline in 24-hour urine protein (UPCR)
The change in urine protein: creatinine ratio (UPCR) from baseline
Change from baseline in 24-hour urine protein(UACR)
The change in urine albumin: creatinine ratio (UACR) from baseline
Change from baseline in 24-hour urine protein
The change in urine protein excretion from baseline
Proportion Change from baseline in 24-hour urine protein
The proportion of patients with urinary protein equivalent of \< 0.3 g/24 hours
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This trial is not recruiting at the moment. You can still explore other options:
