Clinical trial NCT05691257: Study of the Safety and Efficacy of Roxadustat in the Treatment of Heart Failure With Chronic Kidney Disease and Anemia
Official title: Study of the Safety and Efficacy of Roxadustat in the Treatment of Heart Failure With Chronic Kidney Disease and Anemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Heart Failure
Chronic Kidney Diseases
Anemia
Keywords: Roxadustat
Anemia
Biomarkers
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to conduct a a cohort study to evaluate the efficacy and safety of the efficacy and safety of roxadustat for the treatment of anemia, quality of life and cardiac function in patients with heart failure and chronic kidney disease.

Detailed description: This is a cohort study in patients with anemia with heart failure complicated with chronic kidney disease, evaluating the the efficacy and safety of roxadustat. Patients were divided into roxadustat group and control group according to whether roxadustat was used or not. The efficacy and safety of roxadustat for the treatment of anemia, quality of life and cardiac function in patients with heart failure and chronic kidney disease will be evaluated.

The primary and secondary endpoints will be examined in subgroups determined by baseline variables reflecting demography, heart failure characteristics, diabetes status, kidney function, cardiac function, natriuretic peptide, dialysis, and additional co-morbidities, concomitant medications, and others.

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.

Primary outcomes:
measure: Change in the hemoglobin from baseline
timeFrame: up to 8 week
Secondary outcomes:
measure: Change in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
timeFrame: Up to 8 weeks
measure: Change in Left Ventricular Systolic Function
timeFrame: Up to 24 weeks
measure: Change in Left Ventricular End-Diastolic Diameter
timeFrame: Up to 24 weeks
measure: Change in Left Ventricular Diastolic Function
timeFrame: Up to 24 weeks
measure: Change in Low-density lipoprotein（LDL）
timeFrame: Up to 8 weeks
measure: Change in Serum ferritin
timeFrame: Up to 8 weeks
measure: Change in Transferrin saturation
timeFrame: Up to 8 weeks
measure: Change in Left atrial volume
timeFrame: Up to 24 weeks
measure: Change in Left atrial volume index
timeFrame: Up to 24 weeks
Other outcomes:
measure: Liver Injury
timeFrame: Up to 8 weeks
measure: Hyperkalemia
timeFrame: Up to 8 weeks
measure: Thromboembolism
timeFrame: Up to 1 year
Locations:
Study officials:
References: