Study of the Safety and Efficacy of Roxadustat in the Treatment of Heart Failure With Chronic Kidney Disease and Anemia
Heart Failure, Chronic Kidney Diseases, Anemia
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Roxadustat, Anemia, Biomarkers
Eligibility Criteria
Inclusion Criteria: Male or female, aged ≥18 years at the time of consent Weight between 45-160kg Definite diagnosis of heart failure: according to the diagnostic criteria for heart failure in "Chinese Heart Failure Diagnosis and Treatment Guidelines 2018" eGFR <60mL/min/1.73 m^2 by CKD-EPI. Diagnosed anemia: male hemoglobin <130 g/L, non-pregnant female hemoglobin <120 g/L. Provision of signed informed consent prior to any study specific procedures. Exclusion Criteria: Acute or chronic active bleeding 6 months before enrollment. Anemias due to thalassemia, sickle cell anemia, pure red aplastic anemia, hemolytic anemia, ect. Thromboembolism requiring anticoagulation. Severe Infection. Hepatic impairment aspartate transaminase [AST] or alanine transaminase [ALT] >3x the upper limit of normal [ULN]; or total bilirubin >2x ULN at time of enrolment). Severe malnutrition. Women of child-bearing potential who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator OR women who have a positive pregnancy test at enrolment or randomization OR women who are breast-feeding. Patients who have received roxadustat treatment or are allergic to roxadustat.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Roxadustat group
Control group
Roxadustat group: patients with heart failure and chronic kidney disease and anemia treated with roxadustat and other anemia correction drugs.
Control group: patients with heart failure and chronic kidney disease and anemia who were treated with other drugs include: Recombinant human eythropoietin (RH-EPO), iron agents (ferrous succinate, polysaccharide iron complex, iron sucrose, etc.)