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This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group and event-driven phase III clinical trial. The aim of this trial is to confirm the superiority of HRS-7535 over placebo in reducing the risks of renal outcomes and cardiovascular death among participants with chronic kidney disease (CKD) on the basis of standard of care
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A, Participants will receive HRS-7535 tablets administered orally | Experimental |
| |
| Group B, Participants will receive matching placebo tablets administered orally | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-7535 | Drug | HRS-7535 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first occurrence of any of the following renal composite endpoint events |
| Up to approximately 4.8 years |
| Measure | Description | Time Frame |
|---|---|---|
| Annual rate of change in estimated glomerular filtration rate (eGFR) from baseline to 24 Month of treatment; | From baseline to Month 24 | |
| Percentage change in urine albumin-to-creatinine ratio (UACR) from baseline at Month 9 of treatment; | At Month 9 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liang Peng | Contact | 0518-82342973 | liang.peng.lp1@hengrui.com | |
| Chen Xu | Contact | 0518-82342973 | chen.xu@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | 300052 | 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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| Placebo |
| Drug |
Placebo |
|
| Change in systolic blood pressure from baseline at Month 9 of treatment. | At Month 9 |
| Time to first diagnosis of diabetes for participants without diabetes at baseline; | Up to approximately 4.8 years |
| Time to first occurrence of any cardiovascular composite endpoint event (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke). | Up to approximately 4.8 years |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310003 | China |
|
| 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 |