Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-24 @ 6:48 PM
NCT ID:
NCT05691257
Eligibility Criteria:
Inclusion Criteria:
1. Male or female, aged ≥18 years at the time of consent
2. Weight between 45-160kg
3. Definite diagnosis of heart failure: according to the diagnostic criteria for heart failure in "Chinese Heart Failure Diagnosis and Treatment Guidelines 2018"
4. eGFR \<60mL/min/1.73 m\^2 by CKD-EPI.
5. Diagnosed anemia: male hemoglobin \<130 g/L, non-pregnant female hemoglobin \<120 g/L.
6. Provision of signed informed consent prior to any study specific procedures.
Exclusion Criteria:
1. Acute or chronic active bleeding 6 months before enrollment.
2. Anemias due to thalassemia, sickle cell anemia, pure red aplastic anemia, hemolytic anemia, ect.
3. Thromboembolism requiring anticoagulation.
4. Severe Infection.
5. 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).
6. Severe malnutrition.
7. 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.
8. Patients who have received roxadustat treatment or are allergic to roxadustat.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05691257
Study Brief:
Protocol Section:
NCT05691257