Study of the Safety and Efficacy of Roxadustat in the Treatment of Heart Failure With Chronic Kidney Disease and Anemia

China-Japan Friendship Hospital

Status and phase: Not yet enrolling; Phase 4

Conditions: Anemia; Chronic Kidney Diseases; Heart Failure

Treatments: Drug: Roxadustat; Drug: Recombinant human eythropoietin and/or Iron agents

Study type: Interventional

Funder types: Other

Identifiers

NCT05691257

JRen

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Roxadustat group

Experimental group

Description:

Roxadustat group: patients with heart failure and chronic kidney disease and anemia treated with roxadustat and other anemia correction drugs.

Treatment:

Drug: Roxadustat

Drug: Recombinant human eythropoietin and/or Iron agents

Control group

Other group

Description:

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.)

Treatment:

Drug: Recombinant human eythropoietin and/or Iron agents