Efficacy and Safety of SPH3127 Tablets on Treating the Diabetic Kidney Disease
- Conditions
- Diabetic Kidney Disease
- Interventions
- Drug: SPH3127 matching placebo+valsartanDrug: SPH3127+SPH3127matching placebo+valsartan matching placeboDrug: SPH3127+valsartan matching placebo
- Registration Number
- NCT05593575
- Lead Sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 305
- Subjects who are diagnosed with type 2 diabetes who have been treated with at least one hypoglycemic therapy within 12 months prior to screening, with basically stable blood glucose level during screening;
- During screening period, 120 mmHg ≤ sitting SBP ≤ 160 mmHg and sitting DBP < 110 mmHg;
- Laboratory results before randomization should be: 1) at least twice the result of UCAR 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 spouses throughout 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 study procedures and voluntarily sign the informed consent form prior to their participation in the trial.
- 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, kidney stone, nephrotic syndrome; ③there is evidence that proteinuria originates from primary and secondary renal diseases other than hypertensive renal damage; ④ gross hematuria in the past one year.
- During the screening/run-in period, major modifications need to be made to the subject's corresponding treatment regimen due to poor control of other underlying diseases based on the investigator's judgement;
- Subjects with fundus lesions in malignant hypertensive, such as retinal hemorrhage and papilledema;
- Subjects who need to continuously take glucocorticoids, anti-tumor chemical or biological agents, and non-steroidal anti-inflammatory drugs during the study period;
- Subjects with a history of acute myocardial infarction, coronary artery revascularization, Class IV heart failure, acute cerebral infarction, cerebral hemorrhage 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 need to 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 change the absorption, distribution, metabolism and excretion of drugs;
- Subjects who are known to be allergic to renin inhibitors, ARBs, ACEIs and their excipients, or those with hypersensitive constitution, or those who experience serious 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 other active infections;
- Subjects who have a history of malignant tumor, and those who are suspected of malignant 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 to screening;
- Subjects who have participated in clinical trials of other drugs/devices as a subject within 3 months prior to screening;
- Subjects with other diseases or conditions that the investigator considers not suitable for this trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SPH3127-4 SPH3127 matching placebo+valsartan 4 tablets of SPH3127 (50mg)matching placebo， 1 capsule of valsartan , orally, once daily for 12 consecutive weeks SPH3127-1 SPH3127+SPH3127matching placebo+valsartan matching placebo 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 SPH3127-3 SPH3127+valsartan matching placebo 4 tablet of SPH3127 (50 mg) ，1 capsule of valsartan matching placebo, orally, once daily for 12 consecutive weeks SPH3127-2 SPH3127+SPH3127matching placebo+valsartan matching placebo 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
- Primary Outcome Measures
Name Time Method Percentage change from baseline in UACR at the end of Week 12 of treatment Percentage change from baseline in log-transformed UACR at the end of Week 12 of treatment
- Secondary Outcome Measures
Name Time Method Percentage change from baseline in UACR at the end of Weeks 2, 4 and 8 of treatment Percentage change from baseline in log-transformed UACR at the end of Weeks 2, 4 and 8 of treatment
Percentage change from baseline in UPCR at the end of Weeks 2, 4, 8 and 12 of treatment Percentage change from baseline in log-transformed UPCR at the end of Weeks 2, 4, 8 and 12 of treatment
The change trend of eGFR from baseline to the end of Weeks 2, 4, 8 and 12 of treatment The change trend of eGFR from baseline to the end of Weeks 2, 4, 8 and 12 of treatment
Trial Locations
- Locations (45)
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
Zigong Fourth People's Hospital
🇨🇳Zigong, Sichuan, China
Beijing Tiantan Hospital，Capital Medical University
🇨🇳Beijing, China
Beijing Tongren Hospital
🇨🇳Beijing, China
Peking Union Medical College Hospital
🇨🇳Beijing, China
Beijing Tsinghua Changgeng Hospital
🇨🇳Beijin, 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
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
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
🇨🇳Chang chun, 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
The First Affiliated Hospital of Xinjiang Medical University
🇨🇳Ürümqi, Xinjiang, China
Taizhou Municipal Hospital
🇨🇳Taizhou, Zhejiang, China
Beijing Anzhen Hospital，Capital Medical University
🇨🇳Beijing, 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