JRCT ID: jRCTs041200108
Registered date:08/03/2021
The effects of dapagliflozin on anemia of chronic kidney disease (Study B)
Basic Information
Recruitment status | Recruiting |
---|---|
Health condition(s) or Problem(s) studied | Chronic kidney disease stage 3-4 with anemia of chronic kidney disease |
Date of first enrollment | 31/05/2021 |
Target sample size | 96 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | dapagliflozin |
Outcome(s)
Primary Outcome | Time to first event of Hb<10.5 g/dL or initiation of ESA |
---|---|
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 (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) |
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 |
---|---|
Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Minamo Ono |
Address | 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi Aichi Japan 467-8602 |
Telephone | +81-52-858-7429 |
minamo@med.nagoya-cu.ac.jp | |
Affiliation | Nagoya City University Hospital |
Scientific contact | |
Name | Takayuki Hamano |
Address | 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi Aichi Japan 467-8602 |
Telephone | +81-52-858-7429 |
hamatea@med.nagoya-cu.ac.jp | |
Affiliation | Nagoya City University Hospital |