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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
305
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
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
4 tablet of SPH3127 (50 mg) , 1 capsule of valsartan matching placebo, orally, once daily for 12 consecutive weeks
Percentage change from baseline in UACR
Percentage change from baseline in log-transformed UACR at the end of Week 12 of treatment
Time frame: at the end of Week 12 of treatment
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
Time frame: at the end of Weeks 2, 4 and 8 of treatment
Percentage change from baseline in UPCR
Percentage change from baseline in log-transformed UPCR at the end of Weeks 2, 4, 8 and 12 of treatment
Time frame: 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
Time frame: from baseline to the end of Weeks 2, 4, 8 and 12 of treatment
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4 tablets of SPH3127 (50mg)matching placebo, 1 capsule of valsartan, orally, once daily for 12 consecutive weeks
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
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
...and 35 more locations