Diabetic kidney disease
Conditions
Interventions
Experimental group:Canagliflozin
Sponsors
Department of Nephrology, Shenzhen Second People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients aged >= 18 years old with type 2 diabetes mellitus and glycosylated hemoglobin [6.5%, 12.0%]. 2. Patients with chronic kidney disease (EGFR determined by CKD-EPI formula is [30120) ml / (1.73m2 · min). 3. Patients with albuminuria (UACR = 300-5000 mg / g). If UACR is measured unconditionally, it can be replaced by one of the following: albumin excretion rate > 300mg / 24h, urinary protein creatinine ratio (PCR) > 500mg / g (> 56.5mg / mmol), protein excretion rate > 500mg / 24h. 4. Patients who had received ACEI or ARB at least 4 weeks before admission. Note: according to ACEI or ARB's instructions, the maximum tolerable daily dose is defined as: the maximum approved label dose of diabetic nephropathy (for the drugs used for diabetic nephropathy in T2DM patients included in the approved indications, i.e. losartan and irbesartan) or the maximum approved dose used for hypertension (for the drugs not included in the approved indications). For subjects who did not receive the maximum daily dose ACEI or ARB specified in the instructions, the reason for limiting the use of the maximum tolerable dose should be recorded.
Exclusion criteria
Exclusion criteria: 1. With history of diabetic ketoacidosis or type 1 diabetes mellitus (T1DM). 2. With history of hereditary glucose-galactose malabsorption or primary renal glucosuria. 3. With known medical history or clinical evidence suggesting nondiabetic renal disease. 4. With renal disease that required treatment with immunosuppressive therapy or a history of chronic dialysis or renal transplant. Note: Subjects with a history of treated childhood renal disease, without sequelae, may participate. 5. With uncontrolled hypertension (systolic blood pressure [BP] >= 180 and/or diastolic BP >= 100 mmHg). Note: Subjects not fulfilling BP criteria may have their BP-lowering medication regimen adjusted until study initiation (the ACEI or ARB regimen must be stable for at least 4 weeks before study treatment). 6. Blood potassium level > 5.5 mmol/L. Note: Subjects in whom hyperkalemia was associated with the use of nonsteroidal anti-inflammatory drugs (NSAIDs), ß-blockers, or mineralocorticoid receptor antagonists (MRAs; e.g., spironolactone or eplerenone), who have been withdrawn from these drugs, and in whom usage of these drugs is not indicated in the view of the treating physician, may be included in the study. 7. With myocardial infarction, unstable angina, revascularization procedure (e.g., stent or bypass graft surgery), or cerebrovascular accident within 12 weeks before treatment, or a revascularization procedure is planned during the study. 8. With current or history of heart failure of New York Heart Association (NYHA) class IV cardiac disease (The Criteria Committee of the NYHA). 9. Electrocardiogram (ECG) findings within 12 weeks before treatment that would require urgent diagnostic evaluation or intervention (e.g., new clinically important arrhythmia or conduction disturbance). 10. With known significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis). 11. Alanine aminotransferase (ALT) levels > 2.0 times the upper limit of normal (ULN) or total bilirubin >1.5 times the ULN, unless in the opinion of the investigator, the findings are consistent with Gilberts disease. 12. With history of malignancy within 5 years before treatment (exceptions: squamous and basal cell carcinomas of the skin and carcinoma of the cervix in situ, or a malignancy that in the opinion of the investigator, is considered cured with minimal risk of recurrence). 13. With history of human immunodeficiency virus (HIV) antibody positive. 14. Patients with major surgery or incomplete recovery within 12 weeks before admission. 15. There are situations that are not conducive to the maximization of the interests of the subjects or may prevent, limit or confuse the evaluation of program provisions. 16. Patients with non-invasive amputation or active skin ulcer, gangrene, severe ischemia and osteomyelitis of lower limbs within 12 weeks before admission. 17. Combined application of ACEI and ARB. 18. Patients with direct renin inhibitor (DRI) or corticosteroid receptor antagonist (MRA). Note: the investigator may stop the DRI or MRA treatment of the subject at his / her discretion before entering the group if the clinical situation allows. Those who have stopped DRI or MRA treatment for at least 8 weeks before enrollment may be eligible for inclusion in the trial. 19. Patients who used SGLT2 inhibitors within 12 weeks before enrollment. 20. Patients who currently or in the past were involved in another study on gagrinine. 21. Patients who a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum creatinine;Glycosylated hemoglobin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Urinary albumin creatinine ratio; | — |
Countries
China
Contacts
Public ContactQijun Wan
Department of Nephrology, Shenzhen Second People's Hospital
Outcome results
None listed