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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HS-10390; high dose | Experimental | HS-10390; high dose |
|
| HS-10390; low dose | Experimental | HS-10390; low dose |
|
| irbesartan | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-10390 | Drug | HS-10390 will be administered daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in 24-hour urine protein at Week 12 | The change in urine protein: creatinine ratio (UPCR) from baseline to Week 12 | up to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in 24-hour urine protein (UPCR) | The change in urine protein: creatinine ratio (UPCR) from baseline | up to Week 12 |
| Change from baseline in 24-hour urine protein(UACR) | The change in urine albumin: creatinine ratio (UACR) from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jicheng Lv, PhD | Contact | +8613161753111 | chenglv@263.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | China |
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| ID | Term |
|---|---|
| D005922 | Glomerulonephritis, IGA |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D000077405 | Irbesartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Irbesartan | Drug | 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 |
|
| up to Week 12 |
| Change from baseline in 24-hour urine protein | The change in urine protein excretion from baseline | 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 | up to Week 12 |
| change from baseline in Estimated Glomerular Filtration Rate | change from baseline in Estimated Glomerular Filtration Rate (eGFR) | up to Week 12 |
| Number of subjects with adverse events (AEs) | Type, incidence, severity, seriousness, and relatedness of AEs will be collected | up to Week 12 |
| Plasma Concentration of HS-10390 | Blood samples will be collected for the measurement of plasma concentrations of HS-10390 | up to Week 12 |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D013141 | Spiro Compounds |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |