HIF_PHi study

JRCT ID: jRCT1051210196

Registered date:18/03/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Heart Failure with Renal Anemia
• Date of first enrollment: 18/03/2022
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

randomized controlled

[Pharmaceuticals] Derblock (generic name: daprodustat)
Dosage and administration method when untreated with erythropoiesis stimulating factor preparation
The usual starting dose for adults is 2 mg or 4 mg of daprodustat, which is orally administered once daily. After that, the dose may be adjusted according to the patient's condition, but the maximum dose should be up to 24 mg once a day.

Outcome(s)

• Primary Outcome: Hemoglobin level at 16 weeks after randomization

Secondary Outcome

The following items at 16 weeks after randomization
1) Presence or absence of red blood cell transfusion by 16 weeks after randomization
2) Presence or absence of score from 0 to 100 (KCCQ-TSS) calculated by the questionnaire on heart failure symptoms increased by 5 points or more compared to the baseline.
3) Blood tests :NT-proBNP, high-sensitivity troponin T, serum iron,transferrin,total iron binding capacity,transferrin saturation,ferritin,hepcidin,high-sensitivity C-reactive protein,total cholesterol,triglyceride,HDL cholesterol,LDL cholesterol,TNF-alpha,IL-1beta,IL-6, VEGF (plasma),angiopoietin
4) Echocardiography:left and right ventricular function analysis using M-mode,color Doppler,tissue Doppler,and strain analysis at the following cross sections Short-axis images (apex,papillary muscle level,mitral valve level), four-lumen,two-lumen,three-lumen images,right ventricle-focused four-lumen view of the apex (RV focused four chamber view)
5) Cardiac MRI:left and right heart function including strain analysis on cine MRI,native T1 abnormality and extracellular volume fraction on T1 mapping.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 90age old
• Gender: Both

Include criteria

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.

Exclude criteria

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

Related Information

• Primary Sponsor: Minamino Tohru