Effects of Enalodustat on Heart Failure Patients with Renal Anemia

JRCT ID: jRCT1041240013

Registered date:10/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Heart failure with renal anemia
• Date of first enrollment: 10/04/2024
• Target sample size: 30
• Study type: Observational

Outcome(s)

• Primary Outcome: Calculate the 95% confidence interval for the percentage of patients achieving an Hb concentration between 10.0 g/dL and 12.0 g/dL for the evaluation period.

Secondary Outcome

Echocardiographic evaluation (measurement items LVEF left ventricular myocardial weight)
Cardiac markers BNP, NT pro BNP
Renal markers Urine-FABP, urine NAG, urine b2-microglobulin, urine protein, serum creatinine, eGFR
Anemia markers Hemoglobin, serum iron, transferrin, TIBC, TSAT, ferritin, MCV/MCH/MCHC, hepcidin
Exploratory markers PGC1a , PINK1 , Parkin , PKM2

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.NYHA II or III
2.eGFR 60mL/min/1.73m2
3.BNP 100 pg /mL or NT pro BNP 600 pg /mL
4.Ferritin/TSAT>100ng/mL and 20%

Exclude criteria

(1) Patients with any of the following
Patients with malignant tumors
Patients on immunosuppressive drugs
Patients on immunosuppressive drugs
Patients on dialysis
(ii) Other research subjects who are deemed inappropriate for the safe conduct of this study by the principal investigator or physician in charge.

Related Information

• Primary Sponsor: Mima Akira
• Source(s) of Monetary Support: Torii Pharmaceutical Co., LTD