Diabetic nephropathy
Conditions
Interventions
SGLT2 inhibitor
Standard care
Sponsors
Nihon University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. type 2 diabetes with nephropathy under stable glycemic control, defined as a HbA1c level <10.0% after administration of oral anti-diabetic agents or insulin injection therapy for 8 consecutive weeks; 2) albuminuria: urinary albumin to creatinine (Cr) ratio (UACR) 30 to 2000 mg/g (average of two consecutive measurements recorded during the 8-week pre-treatment period); 3) estimated glomerular filtration rate (eGFR) of 45-89 mL/min/1.73 m2; and 4) hypertension who were treated with a fixed dose of RAS inhibitors for at least 8 weeks before the study.
Exclusion criteria
Exclusion criteria: 1) age <20 years or >85 years; 2) eGFR >90 mL/min/1.73 m2 or <45 mL/min/1.73 m2; 3) HbA1c >10.0%; 4) severe heart failure, angina, myocardial infarction, or stroke occurring within 6 months before the trial; and 5) previous treatment with SGLT2 inhibitors for at least 8 weeks before the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in albuminuria and hemoglobin | — |
Secondary
| Measure | Time frame |
|---|---|
| Urinary L-FABP, NAG, Beta2-microglobulin, eGFR, and safety | — |
Countries
Japan
Contacts
Public ContactMasanori Abe
Nihon University Itabashi Hospital Nephrology, Hypertension and Endocrinology
Outcome results
None listed