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This multicenter, randomized, double-blind, parallel, placebo-controlled study is being conducted to evaluate the efficacy, and safety of HRS-5965 capsule for primary IgA nephropathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental | HRS-5965 |
|
| Treatment group B | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-5965 | Drug | HRS-5965 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of 24-hour Urinary protein to creatinine ratio (UPCR) to baseline | Baseline and Week 36 | |
| The total annualized slope of estimated glomerular filtration rate(eGFR) | Baseline and Week 104 |
| Measure | Description | Time Frame |
|---|---|---|
| The total annualized slope of estimated glomerular filtration rate(eGFR) | up to Week 36 | |
| Proportion of subjects with 24-hour urinary protein excretion (24-UPE) < 0.5 g/d and < 0.3 g/d | up to Week 36 and Week104 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sheng Qi | Contact | +86 0518 82342973 | Sheng.qi@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | 100034 | 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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| Drug |
Placebo |
|
| Proportion of subjects with 24-UPCR declined >50% to baseline | up to Week 36 and Week104 |
| Ratio of 24-hour Urinary protein to creatinine ratio (24-UPCR) to baseline | up to Week 36 and Week104 |
| Ratio of 24-hour Urinary protein to Albumin Creatinine ratio (24-UACR) to baseline | up to Week 36 and Week104 |
| Ratio of 24-hour Urinary protein excretion(24-UPE) to baseline | up to Week 36 and Week104 |
| Change from baseline of eGFR | up to Week 36 and Week104 |
| Change from baseline of serum creatinine | up to Week 36 and Week104 |
| 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 |