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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ganagliflozin | Experimental | 50 mg Once daily, 120 weeks |
|
| placebo | Placebo Comparator | 50 mg Once daily, 120 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ganagliflozin | Drug | 50 mg Once daily, 120 weeks |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The average change in eGFR as measured by the total slope of eGFR from baseline to week 120 | Baseline to Week 120 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to the first occurrence of kidney disease progression | The progression of kidney disease is defined as:
| from baseline to Week 120 |
| Measure | Description | Time Frame |
|---|---|---|
| time to the first occurrence of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for heart failure | from baseline to week 120 | |
| Changes in liver stiffness measurement (LSM) of liver transient elastography | from baseline to week 52 and 120 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaofen Qian | Contact | +86-0571-89908582 | qianxiaofen@eastchinapharm.com | |
| Wanting Zhang | Contact | +86-0571-89905517 | zhangwanting@eastchinapharm.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai sixth People's Hospital | Shanghai | Shanghai Municipality | China |
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| Drug |
50 mg Once daily, 120 weeks |
|
| The proportion of subjects with a total slope of eGFR greater than -3 mL/min/1.73 m²/year from baseline to week 120 | 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 | 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 | 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 | 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 | from baseline to week 120 |
| change in the staging of diabetic retinopathy measured by non-mydriatic fundus photography | from baseline to week 52 and 120 |
| Changes in control attenuation index (Cap) of liver transient elastography | from baseline to week 52 and 120 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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