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

NCT ID: NCT05691257

Last Updated: 2023-01-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2023-12-01

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.

Conditions

Heart Failure; Chronic Kidney Diseases; Anemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Roxadustat group

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

Group Type: EXPERIMENTAL

Roxadustat

Intervention Type: DRUG

The initial dose of roxadustat was given according to body weight, which was more than 60kg: 100mg (three times a week); Weight less than 60kg: 70mg (three times a week); 2 weeks later, the corresponding indexes were rechecked and medication was adjusted according to hemoglobin. The target is hemoglobin 100-120g/L.

Reference for medication Method: The use of roxadustat is the same as the RCT study of roxadustat in the treatment of anemia and the drug instructions of roxadustat published by N Engl J Med in 2019.

Recombinant human eythropoietin and/or Iron agents

Intervention Type: DRUG

Other drugs to treat anemia include: Recombinant human eythropoietin (RH-EPO), iron agents (ferrous succinate, polysaccharide iron complex, iron sucrose, etc.)

Control group

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.)

Group Type: OTHER

Recombinant human eythropoietin and/or Iron agents

Intervention Type: DRUG

Other drugs to treat anemia include: Recombinant human eythropoietin (RH-EPO), iron agents (ferrous succinate, polysaccharide iron complex, iron sucrose, etc.)

Interventions

Roxadustat

The initial dose of roxadustat was given according to body weight, which was more than 60kg: 100mg (three times a week); Weight less than 60kg: 70mg (three times a week); 2 weeks later, the corresponding indexes were rechecked and medication was adjusted according to hemoglobin. The target is hemoglobin 100-120g/L.

Reference for medication Method: The use of roxadustat is the same as the RCT study of roxadustat in the treatment of anemia and the drug instructions of roxadustat published by N Engl J Med in 2019.

Intervention Type: DRUG

Recombinant human eythropoietin and/or Iron agents

Other drugs to treat anemia include: Recombinant human eythropoietin (RH-EPO), iron agents (ferrous succinate, polysaccharide iron complex, iron sucrose, etc.)

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China-Japan Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jingyi Ren

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mengxi Yang

Role: CONTACT

mxtezuka@163.com

+8615120049452

Jiang Liu

Role: CONTACT

+8619800361320

Other Identifiers

JRen

Identifier Type: -

Identifier Source: org_study_id