A Multicenter Randomized Controlled Study of the Efficacy and Safety of Daprodustat in Heart Failure Patients with Renal Anemia

Minamino Tohru0 个研究点目标入组 50 人开始时间: 2022年3月18日最近更新: 2023年10月17日

试验速览

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•Patients meet all of the following selection criteria and do not meet any of the exclusion criteria,will be eligible for the study.
•1)Patients with heart failure who are 20 to 90 years old at the time of obtaining consent
•2)eGFR<60mL/min/1.73m^2 at screening
•3)Patients without atrial fibrillation at screening:BNP >100 pg/mL or NT-proBNP >600 pg/mL
•Patients with atrial fibrillation at screening: BNP >150 pg/mL or NT-proBNP >900 pg/mL
•4)Hemoglobin level >=7.5 g/dL and <11 g/dL at screening
•5)Ferritin level>=100 ng/mL and TSAT>=20% at screening
•6)Folic acid and vitamin B12levels must be above the lower limit of normal at screening.
•7)Patients who have received sufficient explanations for participating in this study and have given their free written consent with full understanding.

•1) NYHA class III/IV
•2) On hemodialysis or peritoneal dialysis, or scheduled to be on hemodialysis in the next 6 months at informed concent
•3) Treated with an ESA within 5 weeks prior to enrollment
•4) Erythrocyte transfusion within 12 weeks prior to enrollment or expected to occur during the study period
•5) Patients who have been treated with HIF-PH inhibitor
•6) Patients with anemia other than chronic kidney disease and current or recent bleeding
•7) History of sickle cell disease, myelodysplastic syndrome, myelofibrosis, hematologic tumor, myeloma, hemolytic anemia, thalassemia, or locus coeruleus
•8) History of pulmonary hypertension, polycystic kidney disease
•9) Malignancy noted within 2 years, except for treated basal cell carcinoma of the skin, squamous cell carcinoma cured by resection, or cervical intraepithelial carcinoma
•10) History of acute myocardial infarction, cerebral infarction, deep vein thrombosis, or pulmonary thromboembolism within 48 weeks prior to enrollment
•11) Others who are judged by the principal investigator to be inappropriate as research subjects

发起方

Minamino Tohru