Chronic kidney disease stage 3-4 and 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 and diabetes mellitus or heart failure with reduced ejection fraction, those with CKD without diabetes or heart failure with reduced ejection fration (eGFR 15-59 mL/min/1.73m2) (2) Those on erythropoiesis stimulating agents (ESA) or hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) inhibitors (3) Those without iron deficiency (transferrin saturation >= 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 |
|---|---|
| The change in dose of ESA/HIF-PH inhibitors | — |
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