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The study is a Phase III clinical trial to evaluate the superiority of HRS-1780 tablets compared with placebo in delaying renal function decline in participants with chronic kidney disease (CKD) on the basis of standard treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-1780 tablets | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-1780 tablets | Drug | Oral tablets |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The annualized total slope of the estimated glomerular filtration rate (eGFR) from baseline to 32 months. | month 32 |
| Measure | Description | Time Frame |
|---|---|---|
| The annualized slope of eGFR from 3 months after randomization to the end of treatment. | month 32 | |
| The ratio of UACR to the baseline. | month 32 | |
| The proportion of participants whose UACR decreased by at least 30% relative to the baseline by the end of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Yue | Contact | +0518-82342973 | yi.yue@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Clinical Research Center of Kidney Diseases, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University | Recruiting | Nanjing | Jiangsu | 210002 | China |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Drug |
Oral tablets |
|
| month 32 |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |