Efficacy and Safety of SPH3127 Tablets on Treating the Diabetic Kidney Disease
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel, Dose-finding Phase 2 Clinical Study to Evaluate the Efficacy and Safety of SPH3127 Tablets in the Treatment of Diabetic Kidney Disease
1 other identifier
interventional
305
1 country
45
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2023
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2022
CompletedFirst Posted
Study publicly available on registry
October 25, 2022
CompletedStudy Start
First participant enrolled
March 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedFebruary 19, 2025
January 1, 2025
1.8 years
October 20, 2022
February 18, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage change from baseline in UACR
Percentage change from baseline in log-transformed UACR at the end of Week 12 of treatment
at the end of Week 12 of treatment
Secondary Outcomes (3)
Percentage change from baseline in 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
The change trend of eGFR
from baseline to the end of Weeks 2, 4, 8 and 12 of treatment
Study Arms (4)
SPH3127-1
EXPERIMENTAL1 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
EXPERIMENTAL2 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
EXPERIMENTAL4 tablet of SPH3127 (50 mg) ，1 capsule of valsartan matching placebo, orally, once daily for 12 consecutive weeks
SPH3127-4
EXPERIMENTAL4 tablets of SPH3127 (50mg)matching placebo， 1 capsule of valsartan , orally, once daily for 12 consecutive weeks
Interventions
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
4 tablet of SPH3127 (50 mg) ， 1 capsule of valsartan matching placebo, orally, once daily for 12 consecutive weeks
4 tablets of SPH3127 (50mg)matching placebo， 1 capsule of valsartan, orally, once daily for 12 consecutive weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
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
Related Publications (1)
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.
PMID: 38682786DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2022
First Posted
October 25, 2022
Study Start
March 22, 2023
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
February 19, 2025
Record last verified: 2025-01