The effects of dapagliflozin on anemia of chronic kidney disease (Study A)

JRCT ID: jRCTs041200107

Registered date:08/03/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic kidney disease stage 3-4 and anemia of chronic kidney disease
• Date of first enrollment: 05/04/2021
• Target sample size: 96
• Study type: Interventional
• Intervention(s): dapagliflozin

Outcome(s)

• Primary Outcome: The change in dose of ESA/HIF-PH inhibitors
• Secondary Outcome: Hemoglobin, erythropoietin, P, Mg, creatinine, blood pressure, body weight, blood sugar, HbA1c or glucoalbumin, ferittin, transferrin saturation, hepcidin, erythroferrone

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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)

Exclude 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

Related Information

• Primary Sponsor: Hamano Takayuki