A Phase 4 interventional study of ganagliflozin and Placebo in T2DM (Type 2 Diabetes Mellitus) and CKD - Chronic Kidney Disease, sponsored by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-18.
Sponsored by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Phase 4, Interventional, and Treatment
This study aims to investigate the impact of adding Ganagliflozin tablets to the current background therapy on preventing the progression of kidney disease in subjects with type 2 diabetes and chronic kidney disease. The efficacy and safety will be evaluated by comparing the effects of Ganagliflozin tablets and placebo tablets added to the current background treatment over 120 weeks
A phase IV clinical study on the efficacy and safety of Ganagliflozin in treating patients with type 2 diabetes and chronic kidney disease (multicenter, randomized, double-blind, placebo parallel controlled). 1244 subjects all received a stable dose of ACEi or ARB for at least 4 weeks before enrollment.
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.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's planned enrollment of 1,244 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. is the lead sponsor of 49 studies on the registry; 38 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
50 mg Once daily, 120 weeks
Drug: ganagliflozin
50 mg Once daily, 120 weeks
Drug: Placebo
50 mg Once daily, 120 weeks
50 mg Once daily, 120 weeks
The average change in eGFR as measured by the total slope of eGFR from baseline to week 120
Time frame: Baseline to Week 120
Time to the first occurrence of kidney disease progression
The progression of kidney disease is defined as: 1. maintenance dialysis or 2. receipt of a kidney transplant or 3. sustained decline in eGFR to \< 15 mL/min/1.73m\^2 or 4. a sustained decline of ≥ 40% in eGFR from baseline or 5. doubling of serum creatinine or 6. renal death
Time frame: from baseline to Week 120
The proportion of subjects with a total slope of eGFR greater than -3 mL/min/1.73 m²/year from baseline to week 120
Time frame: from baseline to week 120
The average change in eGFR as measured by the total slope of eGFR from baseline to week 2 and week 8，from week 2 and week 8 to week 120
Time frame: from baseline to week 2 and week 8，from week 2 and week 8 to week 120
The changes in urine albumin-to-creatinine ratio (UACR) at each visit compared to the baseline
Time frame: from baseline to week 120
Changes in the scores of the Kidney Disease Quality of Life-36 Scale (KDQOL-36) compared to the baseline
The higher the score, the better the patient's quality of life related to CKD
Time frame: from baseline to week 120
Changes in the scores of the European Five-Dimensional Health Scale (EQ-5D-5L) compared to the baseline
Higher the score means the better quality of life
Time frame: from baseline to week 120
time to the first occurrence of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for heart failure
Time frame: from baseline to week 120
Changes in liver stiffness measurement (LSM) of liver transient elastography
Time frame: from baseline to week 52 and 120
change in the staging of diabetic retinopathy measured by non-mydriatic fundus photography
Time frame: from baseline to week 52 and 120
Changes in control attenuation index (Cap) of liver transient elastography
Time frame: from baseline to week 52 and 120
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.