Chronic kidney disease stage 3-4 with anemia of chronic kidney disease Dapagliflozin, diabetes mellitus, chronic kidney disease, anemia of chronic kidney disease, heart failure with reduced ejection fraction
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Those with CKD stage 3-4 (eGFR 15-59 mL/min/1.73m2) and diabetes mellitus or heart failure with reduced ejection fraction, those with CKD (eGFR 15-59 mL/min/1.73m2) without diabetes mellitus or heart failure with reduced ejection fraction (2) Those with anemia by WHO diagnostic criteria (Hb = 20% or ferritin >= 50 ng/mL) (4) Those who are not on SGLT2 inhibitors (5) Those who gave informed consent (6) Age >= 20 years old at the time of consent (both men and women, and inpatients and outpatients) (7) For those with heart failure with reduced ejection fraction, they should be on standard therapy for heart failure (angiotensin converting enzyme inhibitors, angiotensin receptor blockers, diuretics, or beta blockers)
Exclusion criteria
Exclusion criteria: (1) Those with history of allergy to dapagliflozin (2) Those with severe ketoacidosis, hyperosmolar coma or precoma, or type 1 diabetes (3) Those with hospitalization due to infection, surgery under general anesthesia, trauma requiring surgical intervention, gastrointestinal bleeding, transfusion, active malignancy within 3 months, or those expecting surgery within 3 months (4) Those with non-adherence (5) Pregnant or potentially pregnant women (6) Those whom treating physicians judge inappropriate candidates for participating in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first event of Hb<10.5 g/dL or initiation of ESA | — |
Secondary
| Measure | Time frame |
|---|---|
| Hemoglobin, erythropoietin, P, Mg, creatinine, blood pressure, body weight, blood sugar, HbA1c or glucoalbumin, ferittin, transferrin saturation, hepcidin, erythroferrone | — |
Contacts
Nagoya City University Hospital