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This study will evaluate the efficacy and safety of SAL0140 in patients with chronic kidney disease (CKD).
This is a multicenter, randomized, double-blind, placebo-controlled phase II study designed to explore the efficacy and safety of multiple doses of SAL0140 in patients with chronic kidney disease (CKD). 249 participants diagnosed with chronic kidney disease will be randomized in a 1:1:1 ratio into 1 of the 3 treatment groups (placebo, low dose treatment strategy and high dose treatment strategy).
The study will consist of the following 4 periods: screening period, run-in period, double-blind treatment period and follow-up period. Patients will complete the study in approximately 8 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-dose group | Experimental |
| |
| High-dose group | Experimental |
| |
| Placebo group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SAL0140 Tablets | Drug | SAL0140 Tablets |
| |
| SAL0140 Tablets |
| Measure | Description | Time Frame |
|---|---|---|
| The baseline change of UACR | Change from baseline in UACR compared to placebo at Week 16 | at week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhihong Liu, Master | Contact | 025-80862013 | zhliunj@vip.163.com | |
| Zhen Liang, PhD | Contact | 13798304368 | sunylz@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Shenzhen Hospital | Shenzhen | Guangdong | 518036 | China |
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| Drug |
SAL0140 Tablets |
|
| SAL0140 placebo | Drug | placebo |
|
| Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University | Nanjing | Jiangsu | 210002 | China |
|
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| 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 |
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