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

February 18, 2025 updated by: Shanghai Pharmaceuticals Holding Co., Ltd

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
305

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Beijin, China
        • Beijing Tsinghua Changgeng Hospital
      • Beijing, China
        • Beijing Tongren Hospital
      • Beijing, China
        • Beijing Tiantan Hospital,Capital Medical University
      • Beijing, China
        • Peking Union Medical College Hospital
      • Beijing, China
        • Beijing Anzhen Hospital，Capital Medical University
      • Changsha, China
        • Xiangya Hospital Central South University
      • Chengdu, China
        • Sichuan Provincial People's Hospital
      • Chengdu, China
        • West China Hospital of Sichuan University
      • Chengdu, China
        • Chengdu Seventh People's Hospital
      • Foshan, China
        • Shunde Hospital of Southern Medical University
      • Haikou, China
        • The Second Affiliated Hospital of Hainan Medical University
      • Huizhou, China
        • Huizhou First Hospital
      • Jinan, China
        • Qilu Hospital of Shandong University
      • Jinan, China
        • The First Affiliated Hospital of Shandong First Medical University
      • Ningbo, China
        • Ningbo No.2 Hospital
      • Shanghai, China
        • Shanghai Minhang District Central Hospital
      • Shanghai, China
        • Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
      • Shanghai, China
        • Shanghai Fengxian District Central Hospital
      • Shanghai, China
        • Affiliated Zhongshan Hospital of Fudan University，Qingpu Branch
      • Shenyang, China
        • The First Affiliated Hospital of China Medical University
      • Shenyang, China
        • Sheng Jing Hospital of China Medical University
      • Shenzhen, China
        • The Seventh Affiliated Hospital,Sun Yat-sen University
      • Taiyuan, China
        • Second Hospital of Shanxi Medical University
      • Wuhan, China
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
      • Xi'an, China
        • The First Affiliated Hospital of Xi'an Jiaotong University
    • Anhui
      • Hefei, Anhui, China
        • The Second Hospital of Anhui Medical University
    • Fujian
      • Fuzhou, Fujian, China
        • The 900 Hospital of the Joint Service Support Force of the People's Liberation Army of China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
      • Guangzhou, Guangdong, China
        • The First Affiliated Hospital，Sun Yat sen University
    • Guangxi
      • Nanning, Guangxi, China
        • The First Affiliated Hospital of Guangxi Medical University
    • Guizhou
      • Guiyang, Guizhou, China
        • Guizhou Provincial People's Hospital
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Harbin Medical University Affiliated Fourth Hospital
    • Henan
      • Luoyang, Henan, China
        • Luoyang Third People's Hospital
    • Hubei
      • Wuhan, Hubei, China
        • Renmin Hospital of Wuhan University
      • Wuhan, Hubei, China
        • The Third Hospital of Wuhan
    • Hunan
      • Changsha, Hunan, China
        • The Third Xiangya Hospital of Central South University
    • Jilin
      • Chang chun, Jilin, China
        • The Second Norman Bethune Hospital of Jilin University
    • Ningxia
      • Yinchuan, Ningxia, China
        • The First People's Hospital of Yinchuan
    • Qinghai
      • Xining, Qinghai, China
        • Qinghai University Affiliated Hospital
    • Shanxi
      • Xi'an, Shanxi, China
        • Xi'an Daxing Hospital
    • Sichuan
      • Chengdu, Sichuan, China
        • Chengdu Second People's Hospital
      • Suining, Sichuan, China
        • Suining Central Hospital
      • Zigong, Sichuan, China
        • Zigong Fourth People's hospital
    • Xinjiang
      • Ürümqi, Xinjiang, China
        • The First Affiliated Hospital of Xinjiang Medical University
    • Zhejiang
      • Taizhou, Zhejiang, China
        • Taizhou Municipal Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Drug: 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
Drug: 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
Experimental: 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
Drug: 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
Drug: 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
Experimental: SPH3127-3
4 tablet of SPH3127 (50 mg) ，1 capsule of valsartan matching placebo, orally, once daily for 12 consecutive weeks
Drug: SPH3127+valsartan matching placebo
4 tablet of SPH3127 (50 mg) ， 1 capsule of valsartan matching placebo, orally, once daily for 12 consecutive weeks
Experimental: SPH3127-4
4 tablets of SPH3127 (50mg)matching placebo， 1 capsule of valsartan , orally, once daily for 12 consecutive weeks
Drug: SPH3127 matching placebo+valsartan
4 tablets of SPH3127 (50mg)matching placebo， 1 capsule of valsartan, orally, once daily for 12 consecutive weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage change from baseline in UACR
Time Frame: at the end of Week 12 of treatment
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage change from baseline in UACR
Time Frame: 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
at the end of Weeks 2, 4 and 8 of treatment
Percentage change from baseline in UPCR
Time Frame: 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
at the end of Weeks 2, 4, 8 and 12 of treatment
The change trend of eGFR
Time Frame: 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
from baseline to the end of Weeks 2, 4, 8 and 12 of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Pharmaceuticals Holding Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 22, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 20, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 25, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SPH3127-202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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