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

Primary Purpose

Diabetic Kidney Disease

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SPH3127+SPH3127matching placebo+valsartan matching placebo
SPH3127+SPH3127matching placebo+valsartan matching placebo
SPH3127+valsartan matching placebo
SPH3127 matching placebo+valsartan
Sponsored by
Shanghai Pharmaceuticals Holding Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Kidney Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. Renal artery stenosis ≥ 50% on one or both sides by color renal artery ultrasound;
  3. ① Acute renal insufficiency: a change ≥ 30% in eGFR during the screening period; ② acute nephritic syndrome, polycystic kidney, kidney stone (confirmed by B-mode ultrasound), 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 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.

Sites / Locations

  • The Second Hospital of Anhui Medical UniversityRecruiting
  • Beijing Anzhen Hospital,Capital Medical UniversityRecruiting
  • Beijing Tiantan Hospital,Capital Medical UniversityRecruiting
  • Beijing Tongren HospitalRecruiting
  • Peking Union Medical College HospitalRecruiting
  • Beijing Tsinghua Changgeng HospitalRecruiting
  • Xiangya Hospital Central South UniversityRecruiting
  • Sichuan Provincial People's HospitalRecruiting
  • West China Hospital of Sichuan UniversityRecruiting
  • The Second Affiliated Hospital of Hainan Medical UniversityRecruiting
  • Qilu Hospital of Shandong UniversityRecruiting
  • The First Affiliated Hospital of Shandong First Medical UniversityRecruiting
  • Ningbo Huamei Hospital, University of the Chinese Academy of SciencesRecruiting
  • Ruijin Hospital affiliated to Shanghai Jiaotong University School of MedicineRecruiting
  • Sheng Jing Hospital of China Medical UniversityRecruiting
  • The First Affiliated Hospital of China Medical UniversityRecruiting
  • The Seventh Affiliated Hospital,Sun Yat-sen UniversityRecruiting
  • Second Hospital of Shanxi Medical UniversityRecruiting
  • Union Hospital Tongji Medical College Huazhong University of Science and TechnologyRecruiting
  • The First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

SPH3127-1

SPH3127-2

SPH3127-3

SPH3127-4

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Percentage change from baseline in UACR
Percentage change from baseline in log-transformed UACR at the end of Week 12 of treatment

Secondary Outcome Measures

Percentage change from baseline in UACR
Percentage change from baseline in log-transformed UACR at the end of Weeks 2, 4 and 8 of treatment
Percentage change from baseline in UPCR
Percentage change from baseline in log-transformed UPCR at the end of Weeks 2, 4, 8 and 12 of treatment
The change trend of eGFR
The change trend of eGFR from baseline to the end of Weeks 2, 4, 8 and 12 of treatment

Full Information

First Posted
October 20, 2022
Last Updated
June 27, 2023
Sponsor
Shanghai Pharmaceuticals Holding Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05593575
Brief Title
Efficacy and Safety of SPH3127 Tablets on Treating the Diabetic Kidney Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2023 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Pharmaceuticals Holding Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Kidney Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SPH3127-1
Arm Type
Experimental
Arm Description
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
Arm Title
SPH3127-2
Arm Type
Experimental
Arm Description
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
Arm Title
SPH3127-3
Arm Type
Experimental
Arm Description
4 tablet of SPH3127 (50 mg) ,1 capsule of valsartan matching placebo, orally, once daily for 12 consecutive weeks
Arm Title
SPH3127-4
Arm Type
Experimental
Arm Description
4 tablets of SPH3127 (50mg)matching placebo, 1 capsule of valsartan , orally, once daily for 12 consecutive weeks
Intervention Type
Drug
Intervention Name(s)
SPH3127+SPH3127matching placebo+valsartan matching placebo
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
SPH3127+SPH3127matching placebo+valsartan matching placebo
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
SPH3127+valsartan matching placebo
Intervention Description
4 tablet of SPH3127 (50 mg) , 1 capsule of valsartan matching placebo, orally, once daily for 12 consecutive weeks
Intervention Type
Drug
Intervention Name(s)
SPH3127 matching placebo+valsartan
Intervention Description
4 tablets of SPH3127 (50mg)matching placebo, 1 capsule of valsartan, orally, once daily for 12 consecutive weeks
Primary Outcome Measure Information:
Title
Percentage change from baseline in UACR
Description
Percentage change from baseline in log-transformed UACR at the end of Week 12 of treatment
Time Frame
at the end of Week 12 of treatment
Secondary Outcome Measure Information:
Title
Percentage change from baseline in UACR
Description
Percentage change from baseline in log-transformed UACR at the end of Weeks 2, 4 and 8 of treatment
Time Frame
at the end of Weeks 2, 4 and 8 of treatment
Title
Percentage change from baseline in UPCR
Description
Percentage change from baseline in log-transformed UPCR at the end of Weeks 2, 4, 8 and 12 of treatment
Time Frame
at the end of Weeks 2, 4, 8 and 12 of treatment
Title
The change trend of eGFR
Description
The change trend of eGFR from baseline to the end of Weeks 2, 4, 8 and 12 of treatment
Time Frame
from baseline to the end of Weeks 2, 4, 8 and 12 of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Sitting SBP >140 mmHg and/or sitting DBP >90 mmHg at baseline (W0); Renal artery stenosis ≥ 50% on one or both sides by color renal artery ultrasound; ① Acute renal insufficiency: a change ≥ 30% in eGFR during the screening period; ② acute nephritic syndrome, polycystic kidney, kidney stone (confirmed by B-mode ultrasound), 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; Subjects with HIV infection, hepatitis B infection, hepatitis C infection, or other active infections; Subjects who have a history of malignant tumor, and those who are suspected of tumor; Subjects with a past and current history of mental illness; Subjects with a history of drug abuse or alcohol abuse within 2 years prior to screening; Subjects who have participated in clinical trials of other drugs/devices as a subject within 3 months prior to screening; Subjects with other diseases or conditions that the investigator considers not suitable for this trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Limeng Chen
Phone
0086+15801391704
Email
chenlimeng@pumch.cn
Facility Information:
Facility Name
The Second Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deguang Wang
Facility Name
Beijing Anzhen Hospital,Capital Medical University
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Cheng
Facility Name
Beijing Tiantan Hospital,Capital Medical University
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yilun Zhou
Facility Name
Beijing Tongren Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guojuan Zhang
First Name & Middle Initial & Last Name & Degree
Jianbo Zhou
Facility Name
Peking Union Medical College Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Limeng Chen
Phone
0086-15801391704
Email
chenlimeng@pumch.cn
Facility Name
Beijing Tsinghua Changgeng Hospital
City
Beijin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuehong Li
Facility Name
Xiangya Hospital Central South University
City
Changsha
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Xu
Facility Name
Sichuan Provincial People's Hospital
City
Chengdu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yurong Zou
Facility Name
West China Hospital of Sichuan University
City
Chengdu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ping Fu
Facility Name
The Second Affiliated Hospital of Hainan Medical University
City
Haikou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bing Li
Facility Name
Qilu Hospital of Shandong University
City
Jinan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhao Hu
Facility Name
The First Affiliated Hospital of Shandong First Medical University
City
Jinan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenbin Li
Facility Name
Ningbo Huamei Hospital, University of the Chinese Academy of Sciences
City
Ningbo
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qun Luo
Facility Name
Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaonong Chen
Facility Name
Sheng Jing Hospital of China Medical University
City
Shenyang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hua Zhou
Facility Name
The First Affiliated Hospital of China Medical University
City
Shenyang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Yao
Facility Name
The Seventh Affiliated Hospital,Sun Yat-sen University
City
Shenzhen
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhihua Zheng
Facility Name
Second Hospital of Shanxi Medical University
City
Taiyuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lihua Wang
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chun Zhang
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aiping Yin

12. IPD Sharing Statement

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

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