Efficacy and Safety of SPH3127 Tablets on Treating the Diabetic Kidney Disease
NCT ID: NCT05593575
Last Updated: 2025-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
305 participants
INTERVENTIONAL
2023-03-22
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SPH3127-1
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+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
SPH3127-2
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+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
SPH3127-3
4 tablet of SPH3127 (50 mg) ，1 capsule of valsartan matching placebo, orally, once daily for 12 consecutive weeks
SPH3127+valsartan matching placebo
4 tablet of SPH3127 (50 mg) ， 1 capsule of valsartan matching placebo, orally, once daily for 12 consecutive weeks
SPH3127-4
4 tablets of SPH3127 (50mg)matching placebo， 1 capsule of valsartan , orally, once daily for 12 consecutive weeks
SPH3127 matching placebo+valsartan
4 tablets of SPH3127 (50mg)matching placebo， 1 capsule of valsartan, orally, once daily for 12 consecutive weeks
Interventions
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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+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
SPH3127+valsartan matching placebo
4 tablet of SPH3127 (50 mg) ， 1 capsule of valsartan matching placebo, orally, once daily for 12 consecutive weeks
SPH3127 matching placebo+valsartan
4 tablets of SPH3127 (50mg)matching placebo， 1 capsule of valsartan, orally, once daily for 12 consecutive weeks
Eligibility Criteria
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Inclusion Criteria
2. During screening period, 120 mmHg ≤ sitting SBP ≤ 160 mmHg and sitting DBP \< 110 mmHg;
3. 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;
4. 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;
5. 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.
Exclusion Criteria
2. Color ultrasonography of renal artery indicated renal artery stenosis;
3. 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.
4. 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;
5. Subjects with fundus lesions in malignant hypertensive, such as retinal hemorrhage and papilledema;
6. Subjects who need to continuously take glucocorticoids, anti-tumor chemical or biological agents, and non-steroidal anti-inflammatory drugs during the study period;
7. 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;
8. Subjects who have abnormal thyroid function tests with clinically significance;
9. Subjects with poor control of diabetes: HbA1c ≥ 9.0% at W0;
10. Subjects who have undergone major surgery within 3 months prior to screening or need to undergo major surgery during the trial;
11. Subjects whose medication adherence in the run-in period is \< 80% or \> 120%;
12. Subjects with a history of gastrointestinal surgery that may significantly change the absorption, distribution, metabolism and excretion of drugs;
13. 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;
14. Women during pregnancy or lactating;
15. Subjects who need transplantation before randomization and during the trial;
16. Subjects with HIV infection, hepatitis B infection, hepatitis C infection, or other active infections;
17. Subjects who have a history of malignant tumor, and those who are suspected of malignant tumor;
18. Subjects with a past and current history of mental illness;
19. Subjects with a history of drug abuse or alcohol abuse within 2 years prior to screening;
20. Subjects who have participated in clinical trials of other drugs/devices as a subject within 3 months prior to screening;
21. Subjects with other diseases or conditions that the investigator considers not suitable for this trial.
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Pharmaceuticals Holding Co., Ltd
INDUSTRY
Responsible Party
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Locations
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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
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
Countries
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References
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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.
Other Identifiers
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SPH3127-202
Identifier Type: -
Identifier Source: org_study_id
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