Ganagliflozin on the Progression of Kidney Disease in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease
NCT ID: NCT07116928
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
1244 participants
INTERVENTIONAL
2025-11-30
2031-12-30
Brief Summary
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Detailed Description
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Efficacy assessment: Compared with the placebo group, time to the first occurrence of kidney disease progression and the changes in eGFR slope, UACR, and score of KDQOL-36 were evaluated.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ganagliflozin
50 mg Once daily, 120 weeks
ganagliflozin
50 mg Once daily, 120 weeks
placebo
50 mg Once daily, 120 weeks
Placebo
50 mg Once daily, 120 weeks
Interventions
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ganagliflozin
50 mg Once daily, 120 weeks
Placebo
50 mg Once daily, 120 weeks
Eligibility Criteria
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Inclusion Criteria
* Meets the diagnostic criteria for T2DM;
* Meets the diagnostic criteria for CKD, during the screening period（CKD-EPI Formula）: eGFR ≥ 30 to \< 60 mL/min/1.73m\^2, and UACR is ≥ 30 to \< 5000 mg/g; Or eGFR ≥ 60 to \< 90 mL/min/1.73m\^2, and UACR is ≥ 300 to \< 5000 mg/g ;
* HbA1c ≥ 6.5% to ≤ 12%;
* If there are no contraindications or special instructions, all subjects must take a stable dose of ACEi or ARB at least 4 weeks before randomization;
Exclusion Criteria
* A medical history or clinical evidence indicating that the subjects have other primary kidney diseases and secondary kidney diseases other than type 2 diabetes (including but not limited to lupus nephritis, ANCA-related nephritis);
* History of kidney transplantation;
* Blood potassium level \> 5.5 mmol/L during the screening period.
* New York Heart Association (NYHA) classification of grade IV during the screening period;
* Experienced ketoacidosis, myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack (TIA), hospitalization due to heart failure, or hospitalization due to urinary tract infection or acute kidney injury within 12 weeks before the screening period;
* Receiving ACEi and ARB in combination;
* Receiving mineralocorticoid receptor antagonists (MRA) or direct renin inhibitors (DRI) within 8 weeks before randomization;
* Receiving drugs with immunosuppressive effects (such as cyclophosphamide, cyclosporine A, tacrolimus, etc.) or biological agents (rituximab, belimumab, etc.) during the 12 weeks before the screening period;
* Receiving SGLT-2 inhibitors or GLP-1 receptor agonists within 8 weeks before the screening, or have previously used SGLT-2 inhibitor drugs and discontinued due to poor efficacy.
18 Years
ALL
No
Sponsors
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Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Shanghai sixth People's Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HDHYJ-LC-2
Identifier Type: -
Identifier Source: org_study_id
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