Efficacy and Safety of SPH3127 Tablets on Treating the Diabetic Kidney Disease

Last updated: February 18, 2025
Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd
Overall Status: Completed

Phase

2

Condition

Diabetic Kidney Disease

Treatment

SPH3127 matching placebo+valsartan

SPH3127+SPH3127matching placebo+valsartan matching placebo

SPH3127+valsartan matching placebo

Clinical Study ID

NCT05593575
SPH3127-202
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 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;

  2. During screening period, 120 mmHg ≤ sitting SBP ≤ 160 mmHg and sitting DBP < 110mmHg;

  3. 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;

  4. Subjects who agree to take effective contraceptive measures with their spousesthroughout 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 studyprocedures and voluntarily sign the informed consent form prior to theirparticipation in the trial.

Exclusion

Exclusion Criteria:

  1. Sitting SBP >140 mmHg and/or sitting DBP >90 mmHg at baseline (W0);

  2. Color ultrasonography of renal artery indicated renal artery stenosis;

  3. 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.

  4. 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;

  5. Subjects with fundus lesions in malignant hypertensive, such as retinal hemorrhageand papilledema;

  6. Subjects who need to continuously take glucocorticoids, anti-tumor chemical orbiological agents, and non-steroidal anti-inflammatory drugs during the studyperiod;

  7. 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;

  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 needto 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 changethe absorption, distribution, metabolism and excretion of drugs;

  13. 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;

  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 otheractive infections;

  17. Subjects who have a history of malignant tumor, and those who are suspected ofmalignant 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 toscreening;

  20. Subjects who have participated in clinical trials of other drugs/devices as asubject within 3 months prior to screening;

  21. Subjects with other diseases or conditions that the investigator considers notsuitable for this trial.

Study Design

Total Participants: 305
Treatment Group(s): 3
Primary Treatment: SPH3127 matching placebo+valsartan
Phase: 2
Study Start date:
March 22, 2023
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui
    China

    Site Not Available

  • The 900 Hospital of the Joint Service Support Force of the People's Liberation Army of China

    Fuzhou, Fujian
    China

    Site Not Available

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong
    China

    Site Not Available

  • The First Affiliated Hospital,Sun Yat sen University

    Guangzhou, Guangdong
    China

    Site Not Available

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi
    China

    Site Not Available

  • Guizhou Provincial People's Hospital

    Guiyang, Guizhou
    China

    Site Not Available

  • Harbin Medical University Affiliated Fourth Hospital

    Harbin, Heilongjiang
    China

    Site Not Available

  • Luoyang Third People's Hospital

    Luoyang, Henan
    China

    Site Not Available

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei
    China

    Site Not Available

  • The Third Hospital of Wuhan

    Wuhan, Hubei
    China

    Site Not Available

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan
    China

    Site Not Available

  • The Second Norman Bethune Hospital of Jilin University

    Chang chun, Jilin
    China

    Site Not Available

  • The First People's Hospital of Yinchuan

    Yinchuan, Ningxia
    China

    Site Not Available

  • Qinghai University Affiliated Hospital

    Xining, Qinghai
    China

    Site Not Available

  • Xi'an Daxing Hospital

    Xi'an, Shanxi
    China

    Site Not Available

  • Chengdu Second People's Hospital

    Chengdu, Sichuan
    China

    Site Not Available

  • Suining Central Hospital

    Suining, Sichuan
    China

    Site Not Available

  • Zigong Fourth People's Hospital

    Zigong, Sichuan
    China

    Site Not Available

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang
    China

    Site Not Available

  • Taizhou Municipal Hospital

    Taizhou, Zhejiang
    China

    Site Not Available

  • Beijing Tsinghua Changgeng Hospital

    Beijin,
    China

    Site Not Available

  • Beijing Anzhen Hospital,Capital Medical University

    Beijing,
    China

    Site Not Available

  • Beijing Tiantan Hospital,Capital Medical University

    Beijing,
    China

    Site Not Available

  • Beijing Tongren Hospital

    Beijing,
    China

    Site Not Available

  • Peking Union Medical College Hospital

    Beijing,
    China

    Site Not Available

  • Xiangya Hospital Central South University

    Changsha,
    China

    Site Not Available

  • Chengdu Seventh People's Hospital

    Chengdu,
    China

    Site Not Available

  • Sichuan Provincial People's Hospital

    Chengdu,
    China

    Site Not Available

  • West China Hospital of Sichuan University

    Chengdu,
    China

    Site Not Available

  • Shunde Hospital of Southern Medical University

    Foshan,
    China

    Site Not Available

  • The Second Affiliated Hospital of Hainan Medical University

    Haikou,
    China

    Site Not Available

  • Huizhou First Hospital

    Huizhou,
    China

    Site Not Available

  • Qilu Hospital of Shandong University

    Jinan,
    China

    Site Not Available

  • The First Affiliated Hospital of Shandong First Medical University

    Jinan,
    China

    Site Not Available

  • Ningbo Huamei Hospital, University of the Chinese Academy of Sciences

    Ningbo,
    China

    Active - Recruiting

  • Ningbo No.2 Hospital

    Ningbo,
    China

    Site Not Available

  • Affiliated Zhongshan Hospital of Fudan University,Qingpu Branch

    Shanghai,
    China

    Site Not Available

  • Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai,
    China

    Site Not Available

  • Shanghai Fengxian District Central Hospital

    Shanghai,
    China

    Site Not Available

  • Shanghai Minhang District Central Hospital

    Shanghai,
    China

    Site Not Available

  • Sheng Jing Hospital of China Medical University

    Shenyang,
    China

    Site Not Available

  • The First Affiliated Hospital of China Medical University

    Shenyang,
    China

    Site Not Available

  • The Seventh Affiliated Hospital,Sun Yat-sen University

    Shenzhen,
    China

    Site Not Available

  • Second Hospital of Shanxi Medical University

    Taiyuan,
    China

    Site Not Available

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan,
    China

    Site Not Available

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an,
    China

    Site Not Available

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