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

Phase 4

Not yet recruiting

• Conditions: Heart Failure; Chronic Kidney Diseases; Anemia
• Interventions: Drug: Roxadustat; Drug: Recombinant human eythropoietin and/or Iron agents

• Registration Number: NCT05691257
• Lead Sponsor: China-Japan Friendship Hospital

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.

Study Timeline

• Study First Submitted: 2022-12-28
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-17
• Last Update Submitted: 2023-01-18
• Study First Posted: 2023-01-19
• Last Update Posted: 2023-01-20
• Study Start: 2023-02-01
• Primary Completion: 2023-08-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Roxadustat group	Recombinant human eythropoietin and/or Iron agents	Roxadustat group: patients with heart failure and chronic kidney disease and anemia treated with roxadustat and other anemia correction drugs.
Roxadustat group	Roxadustat	Roxadustat group: patients with heart failure and chronic kidney disease and anemia treated with roxadustat and other anemia correction drugs.
Control group	Recombinant human eythropoietin and/or Iron agents	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.)

Primary Outcome Measures

Name	Time	Method
Change in the hemoglobin from baseline	up to 8 week	Hemoglobin is calculated by the routine blood test

Secondary Outcome Measures

Name	Time	Method
Change in Left atrial volume	Up to 24 weeks	Change in left atrial volume is assessed by two-dimensional directed M-mode echocardiography
Change in Left atrial volume index	Up to 24 weeks	Change in left atrial volume index is assessed by two-dimensional directed M-mode echocardiography
Change in Left Ventricular Diastolic Function	Up to 24 weeks	Change in E/e' is assessed by two-dimensional directed M-mode echocardiography
Change in Low-density lipoprotein（LDL）	Up to 8 weeks	Change from baseline to week 8 in Low-density lipoprotein（LDL）.Baseline value was defined as the mean of all available measurements from the screening visit until start of treatment with randomised study medication.
Change in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)	Up to 8 weeks	Change from baseline to week 12 in N-terminal pro-brain natriuretic peptide (NT-proBNP). Baseline value was defined as the mean of all available measurements from the screening visit until start of treatment with randomised study medication.
Change in Left Ventricular End-Diastolic Diameter	Up to 24 weeks	Change in left ventricular end-diastolic diameter is assessed by two-dimensional directed M-mode echocardiography
Change in Serum ferritin	Up to 8 weeks	Change from baseline to week 8 in Serum ferritin.Baseline value was defined as the mean of all available measurements from the screening visit until start of treatment with randomised study medication.
Change in Left Ventricular Systolic Function	Up to 24 weeks	Change in left ventricular ejection fraction is assessed by two-dimensional directed M-mode echocardiography
Change in Transferrin saturation	Up to 8 weeks	Change from baseline to week 8 in Transferrin saturation.Baseline value was defined as the mean of all available measurements from the screening visit until start of treatment with randomised study medication.