Phase
Condition
Diabetic Kidney Disease
Treatment
SPH3127 matching placebo+valsartan
SPH3127+SPH3127matching placebo+valsartan matching placebo
SPH3127+valsartan matching placebo
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects who are diagnosed with type 2 diabetes who have been treated with at leastone hypoglycemic therapy within 12 months prior to screening, with basically stableblood glucose level during screening;
During screening period, 120 mmHg ≤ sitting SBP ≤ 160 mmHg and sitting DBP < 110mmHg;
Laboratory results before randomization should be: 1) at least twice the result ofUCAR should be 30 mg/g ≤ UACR < 3000mg/g at W-8, W-4, W-2, and W0; 2) EGFR ≥ 45mL/min/1.73 m2 at W-4 and W0; 3) AST and ALT ≤ 2 times the upper limit of normal (ULN), and total bilirubin ≤ 1.5 times ULN at W0; 4) hemoglobin ≥ 90 g/L at W0; 5) 3.5 mmol/L ≤Serum potassium ≤ 4.8 mmol/L at W-4 and W0;
Subjects who agree to take effective contraceptive measures with their spousesthroughout the study period and for up to 12 weeks after the last dose;
Subjects who thoroughly learn about the nature, significance, possible benefits,possible inconvenience and potential risks of the trial, and understand the studyprocedures and voluntarily sign the informed consent form prior to theirparticipation in the trial.
Exclusion
Exclusion Criteria:
Sitting SBP >140 mmHg and/or sitting DBP >90 mmHg at baseline (W0);
Color ultrasonography of renal artery indicated renal artery stenosis;
① Acute renal insufficiency② acute nephritic syndrome, polycystic kidney, kidneystone, nephrotic syndrome; ③there is evidence that proteinuria originates fromprimary and secondary renal diseases other than hypertensive renal damage; ④ grosshematuria in the past one year.
During the screening/run-in period, major modifications need to be made to thesubject's corresponding treatment regimen due to poor control of other underlyingdiseases based on the investigator's judgement;
Subjects with fundus lesions in malignant hypertensive, such as retinal hemorrhageand papilledema;
Subjects who need to continuously take glucocorticoids, anti-tumor chemical orbiological agents, and non-steroidal anti-inflammatory drugs during the studyperiod;
Subjects with a history of acute myocardial infarction, coronary arteryrevascularization, Class IV heart failure, acute cerebral infarction, cerebralhemorrhage and transient ischemic attack within 3 months prior to randomization;
Subjects who have abnormal thyroid function tests with clinically significance;
Subjects with poor control of diabetes: HbA1c ≥ 9.0% at W0;
Subjects who have undergone major surgery within 3 months prior to screening or needto undergo major surgery during the trial;
Subjects whose medication adherence in the run-in period is < 80% or > 120%;
Subjects with a history of gastrointestinal surgery that may significantly changethe absorption, distribution, metabolism and excretion of drugs;
Subjects who are known to be allergic to renin inhibitors, ARBs, ACEIs and theirexcipients, or those with hypersensitive constitution, or those who experienceserious adverse reactions;
Women during pregnancy or lactating;
Subjects who need transplantation before randomization and during the trial;
Subjects with HIV infection, hepatitis B infection, hepatitis C infection, or otheractive infections;
Subjects who have a history of malignant tumor, and those who are suspected ofmalignant tumor;
Subjects with a past and current history of mental illness;
Subjects with a history of drug abuse or alcohol abuse within 2 years prior toscreening;
Subjects who have participated in clinical trials of other drugs/devices as asubject within 3 months prior to screening;
Subjects with other diseases or conditions that the investigator considers notsuitable for this trial.
Study Design
Connect with a study center
The Second Hospital of Anhui Medical University
Hefei, Anhui
ChinaSite Not Available
The 900 Hospital of the Joint Service Support Force of the People's Liberation Army of China
Fuzhou, Fujian
ChinaSite Not Available
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong
ChinaSite Not Available
The First Affiliated Hospital,Sun Yat sen University
Guangzhou, Guangdong
ChinaSite Not Available
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi
ChinaSite Not Available
Guizhou Provincial People's Hospital
Guiyang, Guizhou
ChinaSite Not Available
Harbin Medical University Affiliated Fourth Hospital
Harbin, Heilongjiang
ChinaSite Not Available
Luoyang Third People's Hospital
Luoyang, Henan
ChinaSite Not Available
Renmin Hospital of Wuhan University
Wuhan, Hubei
ChinaSite Not Available
The Third Hospital of Wuhan
Wuhan, Hubei
ChinaSite Not Available
The Third Xiangya Hospital of Central South University
Changsha, Hunan
ChinaSite Not Available
The Second Norman Bethune Hospital of Jilin University
Chang chun, Jilin
ChinaSite Not Available
The First People's Hospital of Yinchuan
Yinchuan, Ningxia
ChinaSite Not Available
Qinghai University Affiliated Hospital
Xining, Qinghai
ChinaSite Not Available
Xi'an Daxing Hospital
Xi'an, Shanxi
ChinaSite Not Available
Chengdu Second People's Hospital
Chengdu, Sichuan
ChinaSite Not Available
Suining Central Hospital
Suining, Sichuan
ChinaSite Not Available
Zigong Fourth People's Hospital
Zigong, Sichuan
ChinaSite Not Available
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang
ChinaSite Not Available
Taizhou Municipal Hospital
Taizhou, Zhejiang
ChinaSite Not Available
Beijing Tsinghua Changgeng Hospital
Beijin,
ChinaSite Not Available
Beijing Anzhen Hospital,Capital Medical University
Beijing,
ChinaSite Not Available
Beijing Tiantan Hospital,Capital Medical University
Beijing,
ChinaSite Not Available
Beijing Tongren Hospital
Beijing,
ChinaSite Not Available
Peking Union Medical College Hospital
Beijing,
ChinaSite Not Available
Xiangya Hospital Central South University
Changsha,
ChinaSite Not Available
Chengdu Seventh People's Hospital
Chengdu,
ChinaSite Not Available
Sichuan Provincial People's Hospital
Chengdu,
ChinaSite Not Available
West China Hospital of Sichuan University
Chengdu,
ChinaSite Not Available
Shunde Hospital of Southern Medical University
Foshan,
ChinaSite Not Available
The Second Affiliated Hospital of Hainan Medical University
Haikou,
ChinaSite Not Available
Huizhou First Hospital
Huizhou,
ChinaSite Not Available
Qilu Hospital of Shandong University
Jinan,
ChinaSite Not Available
The First Affiliated Hospital of Shandong First Medical University
Jinan,
ChinaSite Not Available
Ningbo Huamei Hospital, University of the Chinese Academy of Sciences
Ningbo,
ChinaActive - Recruiting
Ningbo No.2 Hospital
Ningbo,
ChinaSite Not Available
Affiliated Zhongshan Hospital of Fudan University,Qingpu Branch
Shanghai,
ChinaSite Not Available
Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
Shanghai,
ChinaSite Not Available
Shanghai Fengxian District Central Hospital
Shanghai,
ChinaSite Not Available
Shanghai Minhang District Central Hospital
Shanghai,
ChinaSite Not Available
Sheng Jing Hospital of China Medical University
Shenyang,
ChinaSite Not Available
The First Affiliated Hospital of China Medical University
Shenyang,
ChinaSite Not Available
The Seventh Affiliated Hospital,Sun Yat-sen University
Shenzhen,
ChinaSite Not Available
Second Hospital of Shanxi Medical University
Taiyuan,
ChinaSite Not Available
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan,
ChinaSite Not Available
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an,
ChinaSite Not Available
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