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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,244
50 mg Once daily, 120 weeks
50 mg Once daily, 120 weeks
Shanghai sixth People's Hospital
Shanghai, Shanghai Municipality, China
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.