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The purpose of the study was to evaluate the efficacy and safety of HS-10390 in participants with chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) ≥ 30 and <90 mL/min/1.73 m^2, and urinary albumin to creatinine ratio (UACR) ≥ 150 mg/g and < 3000 mg/g
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HS-10390 Dose A | Experimental | HS-10390 Dose A |
|
| HS-10390 Dose B | Experimental | HS-10390 Dose B |
|
| HS-10390 Dose C | Experimental | HS-10390 Dose C |
|
| Irbesartan | Active Comparator | Irbesartan will be administered daily as a 150-mg oral tablet. Irbesartan will be administered daily as a 150-mg orally for the first 2 weeks of the study following randomization. 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 |
| |
| HS-10390 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Urinary Albumin to Creatinine Ratio (UACR) From Baseline to Week 12 | Frame: From baseline (Day 1) until Week 12 (Day 85) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving ≥20%, ≥30%, and ≥40% reduction in UACR from baseline at week 12 | From baseline (Day 1) until Week 12 (Day 85) | |
| Change in Urine Protein/Creatinine Ratio (UPCR) From Baseline at Each Visit | From baseline (Day 1) at each visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Chen Professor, MD | Contact | 13924150966 | Emailwchen66@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital,Sun Yat-sen University | Guangzhou | Guangdong | 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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| ID | Term |
|---|---|
| D000077405 | Irbesartan |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Drug |
HS-10390 |
|
| HS-10390 | Drug | HS-10390 |
|
| Irbesartan | Drug | Target dose of 300 mg daily |
|
| Change in 24 hour Urinary Protein Excretion From Baseline at Each Visit | From baseline (Day 1) at Each Visit |
| Change in Estimated Glomerular Filtration Rate (eGFR) From Baseline at Each Visit | From baseline (Day 1) at Each Visit |
| Change in Office Systolic and Diastolic Blood Pressure From Baseline at Each Visit | From baseline (Day 1) at Each Visit |
| Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | From screening until Follow-up visit (Day 98) |
| 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 |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D013141 | Spiro Compounds |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |