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

Primary Purpose

Heart Failure, Chronic Kidney Diseases, Anemia

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Roxadustat
Recombinant human eythropoietin and/or Iron agents
Sponsored by
China-Japan Friendship Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Roxadustat, Anemia, Biomarkers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female, aged ≥18 years at the time of consent Weight between 45-160kg Definite diagnosis of heart failure: according to the diagnostic criteria for heart failure in "Chinese Heart Failure Diagnosis and Treatment Guidelines 2018" eGFR <60mL/min/1.73 m^2 by CKD-EPI. Diagnosed anemia: male hemoglobin <130 g/L, non-pregnant female hemoglobin <120 g/L. Provision of signed informed consent prior to any study specific procedures. Exclusion Criteria: Acute or chronic active bleeding 6 months before enrollment. Anemias due to thalassemia, sickle cell anemia, pure red aplastic anemia, hemolytic anemia, ect. Thromboembolism requiring anticoagulation. Severe Infection. 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). Severe malnutrition. 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. Patients who have received roxadustat treatment or are allergic to roxadustat.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Roxadustat group

    Control group

    Arm Description

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

    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.)

    Outcomes

    Primary Outcome Measures

    Change in the hemoglobin from baseline
    Hemoglobin is calculated by the routine blood test

    Secondary Outcome Measures

    Change in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
    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 Systolic Function
    Change in left ventricular ejection fraction is assessed by two-dimensional directed M-mode echocardiography
    Change in Left Ventricular End-Diastolic Diameter
    Change in left ventricular end-diastolic diameter is assessed by two-dimensional directed M-mode echocardiography
    Change in Left Ventricular Diastolic Function
    Change in E/e' is assessed by two-dimensional directed M-mode echocardiography
    Change in Low-density lipoprotein(LDL)
    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 Serum ferritin
    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 Transferrin saturation
    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.
    Change in Left atrial volume
    Change in left atrial volume is assessed by two-dimensional directed M-mode echocardiography
    Change in Left atrial volume index
    Change in left atrial volume index is assessed by two-dimensional directed M-mode echocardiography

    Full Information

    First Posted
    December 28, 2022
    Last Updated
    January 18, 2023
    Sponsor
    China-Japan Friendship Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05691257
    Brief Title
    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

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 1, 2023 (Anticipated)
    Primary Completion Date
    August 1, 2023 (Anticipated)
    Study Completion Date
    December 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    China-Japan Friendship Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure, Chronic Kidney Diseases, Anemia
    Keywords
    Roxadustat, Anemia, Biomarkers

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Roxadustat group
    Arm Type
    Experimental
    Arm Description
    Roxadustat group: patients with heart failure and chronic kidney disease and anemia treated with roxadustat and other anemia correction drugs.
    Arm Title
    Control group
    Arm Type
    Other
    Arm 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.)
    Intervention Type
    Drug
    Intervention Name(s)
    Roxadustat
    Intervention Description
    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
    Intervention Name(s)
    Recombinant human eythropoietin and/or Iron agents
    Intervention Description
    Other drugs to treat anemia include: Recombinant human eythropoietin (RH-EPO), iron agents (ferrous succinate, polysaccharide iron complex, iron sucrose, etc.)
    Primary Outcome Measure Information:
    Title
    Change in the hemoglobin from baseline
    Description
    Hemoglobin is calculated by the routine blood test
    Time Frame
    up to 8 week
    Secondary Outcome Measure Information:
    Title
    Change in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
    Description
    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.
    Time Frame
    Up to 8 weeks
    Title
    Change in Left Ventricular Systolic Function
    Description
    Change in left ventricular ejection fraction is assessed by two-dimensional directed M-mode echocardiography
    Time Frame
    Up to 24 weeks
    Title
    Change in Left Ventricular End-Diastolic Diameter
    Description
    Change in left ventricular end-diastolic diameter is assessed by two-dimensional directed M-mode echocardiography
    Time Frame
    Up to 24 weeks
    Title
    Change in Left Ventricular Diastolic Function
    Description
    Change in E/e' is assessed by two-dimensional directed M-mode echocardiography
    Time Frame
    Up to 24 weeks
    Title
    Change in Low-density lipoprotein(LDL)
    Description
    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.
    Time Frame
    Up to 8 weeks
    Title
    Change in Serum ferritin
    Description
    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.
    Time Frame
    Up to 8 weeks
    Title
    Change in Transferrin saturation
    Description
    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.
    Time Frame
    Up to 8 weeks
    Title
    Change in Left atrial volume
    Description
    Change in left atrial volume is assessed by two-dimensional directed M-mode echocardiography
    Time Frame
    Up to 24 weeks
    Title
    Change in Left atrial volume index
    Description
    Change in left atrial volume index is assessed by two-dimensional directed M-mode echocardiography
    Time Frame
    Up to 24 weeks
    Other Pre-specified Outcome Measures:
    Title
    Liver Injury
    Description
    Liver injury is defined as: i) a rise of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) to 3 times above the upper limit of normal [ULN], or ii) a rise of total bilirubin to 2 times above the upper limit of normal [ULN]
    Time Frame
    Up to 8 weeks
    Title
    Hyperkalemia
    Description
    Hyperkalemia is defined as:Serum potassium > 5.5 mmol/L
    Time Frame
    Up to 8 weeks
    Title
    Thromboembolism
    Description
    Thromboembolism is defined as:Deep vein thrombosis at follow-up
    Time Frame
    Up to 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female, aged ≥18 years at the time of consent Weight between 45-160kg Definite diagnosis of heart failure: according to the diagnostic criteria for heart failure in "Chinese Heart Failure Diagnosis and Treatment Guidelines 2018" eGFR <60mL/min/1.73 m^2 by CKD-EPI. Diagnosed anemia: male hemoglobin <130 g/L, non-pregnant female hemoglobin <120 g/L. Provision of signed informed consent prior to any study specific procedures. Exclusion Criteria: Acute or chronic active bleeding 6 months before enrollment. Anemias due to thalassemia, sickle cell anemia, pure red aplastic anemia, hemolytic anemia, ect. Thromboembolism requiring anticoagulation. Severe Infection. 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). Severe malnutrition. 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. Patients who have received roxadustat treatment or are allergic to roxadustat.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mengxi Yang
    Phone
    +8615120049452
    Email
    mxtezuka@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jiang Liu
    Phone
    +8619800361320

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

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

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