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

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

Hamano Takayuki

Nagoya City University Hospital

1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi

hamatea@med.nagoya-cu.ac.jp

Suzuki Kodai

Nagoya City University Hospital

1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi

+81-52-858-7429

kodais@med.nagoya-cu.ac.jp

Recruiting

Mar. 08, 2021

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

(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 <13 g/dL for men or Hb < 12g/dL for women) with normal or low serum erythropoietin levels and not 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)

(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

Both

Chronic kidney disease stage 3-4 with anemia of chronic kidney disease

dapagliflozin

Dapagliflozin, diabetes mellitus, chronic kidney disease, anemia of chronic kidney disease, heart failure with reduced ejection fraction

Dapagliflozin, SGLT2 inhibitor

Time to first event of Hb<10.5 g/dL or initiation of ESA

Hemoglobin, erythropoietin, P, Mg, creatinine, blood pressure, body weight, blood sugar,
HbA1c or glucoalbumin, ferittin, transferrin saturation, hepcidin, erythroferrone

+81-52-853-8346

Feb. 19, 2021

No

none