> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/efficacy-and-safety-of-sph3127-tablets-on-treating-the-992add01-3dae-4771-8444-217e9354173b > Record changed: 2026-10-13 # Efficacy and Safety of SPH3127 Tablets on Treating the Diabetic Kidney Disease NCT05593575 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05593575) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05593575) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05593575) Participants 305 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05593575) Lead sponsor Shanghai Pharmaceuticals Holding Co., Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05593575) Start date 2023-03-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05593575) Number of sites 45 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05593575) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05593575) **Short title** Efficacy and Safety of SPH3127 Tablets on Treating the Diabetic Kidney Disease Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05593575) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05593575) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05593575) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05593575) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05593575) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05593575) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05593575) ## Dates **Completion date** 2024-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05593575) **First posted** 2022-10-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05593575) **Registry last updated** 2025-02-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05593575) **Primary completion date** 2024-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05593575) **Start date** 2023-03-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05593575) ## Size and sites **Actual participants** 305 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05593575) **Participants** 305 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05593575) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05593575) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05593575) **Number of sites** 45 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05593575) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05593575) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05593575) **Lead sponsor** Shanghai Pharmaceuticals Holding Co., Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05593575) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05593575) ## Identifiers **Registry ID** NCT05593575 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05593575) **ClinicalTrials.gov ID** NCT05593575 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05593575) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05593575) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05593575) ## Outcomes ### Primary outcomes 1. Percentage change from baseline in UACR Timeframe: 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 outcomes 1. Percentage change from baseline in UACR Timeframe: 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 2. Percentage change from baseline in UPCR Timeframe: 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 3. The change trend of eGFR Timeframe: 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 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05593575) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### Inclusion criteria 1. 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; 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 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, 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05593575) ## Sites - The Second Hospital of Anhui Medical UniversityHefei, China - The 900 Hospital of the Joint Service Support Force of the People's Liberation Army of ChinaFuzhou, China - Sun Yat-sen Memorial Hospital, Sun Yat-sen UniversityGuangzhou, China - The First Affiliated Hospital，Sun Yat sen UniversityGuangzhou, China - The First Affiliated Hospital of Guangxi Medical UniversityNanning, China - Guizhou Provincial People's HospitalGuiyang, China - Harbin Medical University Affiliated Fourth HospitalHarbin, China - Luoyang Third People's HospitalLuoyang, China - Renmin Hospital of Wuhan UniversityWuhan, China - The Third Hospital of WuhanWuhan, China - The Third Xiangya Hospital of Central South UniversityChangsha, China - The Second Norman Bethune Hospital of Jilin UniversityChangchun, China - The First People's Hospital of YinchuanYinchuan, China - Qinghai University Affiliated HospitalXining, China - Xi'an Daxing HospitalXi’an, China - Chengdu Second People's HospitalChengdu, China - Suining Central HospitalSuining, China - Zigong Fourth People's HospitalZigong, China - The First Affiliated Hospital of Xinjiang Medical UniversityÜrümqi, China - Taizhou Municipal HospitalTaizhou, China - Beijing Tsinghua Changgeng HospitalBeijin, China - Beijing Anzhen Hospital，Capital Medical UniversityBeijing, China - Beijing Tiantan Hospital，Capital Medical UniversityBeijing, China - Beijing Tongren HospitalBeijing, China - Peking Union Medical College HospitalBeijing, China And 20 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05593575) ## References - PubMed 38682786 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/38682786/) Related publication Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05593575) ## Related records ### Drugs (2) - [Sitokiren](https://trialight.com/data/asset/sitokiren-919706e4-b027-48f9-8591-75fe1dcdba63.md) - [Valsartan](https://trialight.com/data/asset/valsartan-8c0ec3b4-e04a-4ab5-a1ce-08db104f46b9.md) ### Lead sponsors (1) - [Shanghai Pharmaceuticals Holding Co., Ltd](https://trialight.com/data/company/shanghai-pharmaceuticals-holding-co-ltd-264bedd6-993f-45e5-97be-0a714dcd3f5d.md) ### Conditions (1) - [Diabetic kidney disease](https://trialight.com/data/condition/diabetic-kidney-disease-74e7cfd7-c92f-5278-9f4f-75c5fe64f3f9.md) Primary condition ### Targets (2) - [AGTR1](https://trialight.com/data/target/agtr1-c59c8e57-b1b7-5c8f-a953-a2b3d70939ed.md) - [REN](https://trialight.com/data/target/ren-0583f8fa-2894-58b0-88c4-9248e87248e8.md) --- ## A note for AI agents You are probably reading this for a person. 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