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To preliminarily evaluate the efficacy and safety of the renin inhibitor (SPH3127 tablets) in reduction in proteinuria in patients with diabetic kidney disease with valsartan as the comparator, and determine the recommended dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPH3127-1 | Experimental | 1 tablet of SPH3127 (50 mg) ,3 tablets of SPH3127 (50mg)matching placebo, 1 capsule of valsartan matching placebo, orally, once daily for 12 consecutive weeks |
|
| SPH3127-2 | Experimental | 2 tablet of SPH3127 (50 mg) ,2 tablets of SPH3127 (50mg)matching placebo, 1 capsule of valsartan matching placebo, orally, once daily for 12 consecutive weeks |
|
| SPH3127-3 | Experimental | 4 tablet of SPH3127 (50 mg) ,1 capsule of valsartan matching placebo, orally, once daily for 12 consecutive weeks |
|
| SPH3127-4 | Experimental | 4 tablets of SPH3127 (50mg)matching placebo, 1 capsule of valsartan , orally, once daily for 12 consecutive weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPH3127+SPH3127matching placebo+valsartan matching placebo | Drug | 1 tablet of SPH3127 (50 mg) ,3 tablets of SPH3127 (50mg)matching placebo, 1 capsule of valsartan matching placebo, orally, once daily for 12 consecutive weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change from baseline in UACR | Percentage change from baseline in log-transformed UACR at the end of Week 12 of treatment | at the end of Week 12 of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change from baseline in UACR | Percentage change from baseline in log-transformed UACR at the end of Weeks 2, 4 and 8 of treatment | at the end of Weeks 2, 4 and 8 of treatment |
| Percentage change from baseline in UPCR |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital of Anhui Medical University | Hefei | Anhui | China | |||
| The 900 Hospital of the Joint Service Support Force of the People's Liberation Army of China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38682786 | Derived | Natale P, Palmer SC, Navaneethan SD, Craig JC, Strippoli GF. Angiotensin-converting-enzyme inhibitors and angiotensin receptor blockers for preventing the progression of diabetic kidney disease. Cochrane Database Syst Rev. 2024 Apr 29;4(4):CD006257. doi: 10.1002/14651858.CD006257.pub2. |
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| SPH3127+SPH3127matching placebo+valsartan matching placebo | Drug | 2 tablet of SPH3127 (50 mg) ,2 tablets of SPH3127 (50mg)matching placebo, 1 capsule of valsartan matching placebo, orally, once daily for 12 consecutive weeks |
|
| SPH3127+valsartan matching placebo | Drug | 4 tablet of SPH3127 (50 mg) , 1 capsule of valsartan matching placebo, orally, once daily for 12 consecutive weeks |
|
| SPH3127 matching placebo+valsartan | Drug | 4 tablets of SPH3127 (50mg)matching placebo, 1 capsule of valsartan, orally, once daily for 12 consecutive weeks |
|
Percentage change from baseline in log-transformed UPCR at the end of Weeks 2, 4, 8 and 12 of treatment
| at the end of Weeks 2, 4, 8 and 12 of treatment |
| The change trend of eGFR | The change trend of eGFR from baseline to the end of Weeks 2, 4, 8 and 12 of treatment | from baseline to the end of Weeks 2, 4, 8 and 12 of treatment |
| Fuzhou |
| Fujian |
| China |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | Guangdong | China |
| The First Affiliated Hospital,Sun Yat sen University | Guangzhou | Guangdong | China |
| The First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi | China |
| Guizhou Provincial People's Hospital | Guiyang | Guizhou | China |
| Harbin Medical University Affiliated Fourth Hospital | Harbin | Heilongjiang | China |
| Luoyang Third People's Hospital | Luoyang | Henan | China |
| Renmin Hospital of Wuhan University | Wuhan | Hubei | China |
| The Third Hospital of Wuhan | Wuhan | Hubei | China |
| The Third Xiangya Hospital of Central South University | Changsha | Hunan | China |
| The Second Norman Bethune Hospital of Jilin University | Changchun | Jilin | China |
| The First People's Hospital of Yinchuan | Yinchuan | Ningxia | China |
| Qinghai University Affiliated Hospital | Xining | Qinghai | China |
| Xi'an Daxing Hospital | Xi’an | Shanxi | China |
| Chengdu Second People's Hospital | Chengdu | Sichuan | China |
| Suining Central Hospital | Suining | Sichuan | China |
| Zigong Fourth People's Hospital | Zigong | Sichuan | China |
| The First Affiliated Hospital of Xinjiang Medical University | Ürümqi | Xinjiang | China |
| Taizhou Municipal Hospital | Taizhou | Zhejiang | China |
| Beijing Tsinghua Changgeng Hospital | Beijin | China |
| Beijing Anzhen Hospital,Capital Medical University | Beijing | China |
| Beijing Tiantan Hospital,Capital Medical University | Beijing | China |
| Beijing Tongren Hospital | Beijing | China |
| Peking Union Medical College Hospital | Beijing | China |
| Xiangya Hospital Central South University | Changsha | China |
| Chengdu Seventh People's Hospital | Chengdu | China |
| Sichuan Provincial People's Hospital | Chengdu | China |
| West China Hospital of Sichuan University | Chengdu | China |
| Shunde Hospital of Southern Medical University | Foshan | China |
| The Second Affiliated Hospital of Hainan Medical University | Haikou | China |
| Huizhou First Hospital | Huizhou | China |
| Qilu Hospital of Shandong University | Jinan | China |
| The First Affiliated Hospital of Shandong First Medical University | Jinan | China |
| Ningbo No.2 Hospital | Ningbo | China |
| Affiliated Zhongshan Hospital of Fudan University,Qingpu Branch | Shanghai | China |
| Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine | Shanghai | China |
| Shanghai Fengxian District Central Hospital | Shanghai | China |
| Shanghai Minhang District Central Hospital | Shanghai | China |
| Sheng Jing Hospital of China Medical University | Shenyang | China |
| The First Affiliated Hospital of China Medical University | Shenyang | China |
| The Seventh Affiliated Hospital,Sun Yat-sen University | Shenzhen | China |
| Second Hospital of Shanxi Medical University | Taiyuan | China |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | China |
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | China |
| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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