Heart FailurePhase 4NCT05691257
Study of the Safety and Efficacy of Roxadustat in the Treatment of Heart Failure With Chronic Kidney Disease and Anemia
A Phase 4 study testing Roxadustat and Recombinant human eythropoietin and/or Iron agents in people with Heart Failure and Chronic Kidney Diseases, run by China-Japan Friendship Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Chronic Kidney Diseases, Anemia
- What is being tested?
- Roxadustat and Recombinant human eythropoietin and/or Iron agents
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2023to 1 Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
Jiang Liu contact
About this study
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.
Read the 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
- Being tested
- Roxadustat, Recombinant human eythropoietin and/or Iron agents
- Keywords
- Roxadustat, Anemia, Biomarkers
- Medical subject headings
- Heart Failure, Renal Insufficiency, Chronic, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RoxadustatDrug
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 agentsDrug
Other drugs to treat anemia include: Recombinant human eythropoietin (RH-EPO), iron agents (ferrous succinate, polysaccharide iron complex, iron sucrose, etc.)
| Study group | Role | What they receive |
|---|---|---|
| Roxadustat group | Experimental | Roxadustat group: patients with heart failure and chronic kidney disease and anemia treated with roxadustat and other anemia correction drugs. Receives: Drug: Roxadustat; Drug: Recombinant human eythropoietin and/or Iron agents |
| Control group | Other | 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.) Receives: Drug: Recombinant human eythropoietin and/or Iron agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the hemoglobin from baseline
Hemoglobin is calculated by the routine blood test
Measured: up to 8 week
Secondary outcomes (9)
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.
Measured: Up to 8 weeks
Change in Left Ventricular Systolic Function
Change in left ventricular ejection fraction is assessed by two-dimensional directed M-mode echocardiography
Measured: Up to 24 weeks
Change in Left Ventricular End-Diastolic Diameter
Change in left ventricular end-diastolic diameter is assessed by two-dimensional directed M-mode echocardiography
Measured: Up to 24 weeks
Change in Left Ventricular Diastolic Function
Change in E/e' is assessed by two-dimensional directed M-mode echocardiography
Measured: Up to 24 weeks
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.
Measured: Up to 8 weeks
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.
Measured: Up to 8 weeks
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.
Measured: Up to 8 weeks
Change in Left atrial volume
Change in left atrial volume is assessed by two-dimensional directed M-mode echocardiography
Measured: Up to 24 weeks
Change in Left atrial volume index
Change in left atrial volume index is assessed by two-dimensional directed M-mode echocardiography
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start1 Feb 2023 (estimated)
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingyi Ren, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05691257
- Sponsor's protocol ID
- JRen
- Status last verified
- Jan 2023
- First submitted
- 28 Dec 2022
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Safety and Efficacy of Roxadustat in the Treatment of Heart Failure With Chronic Kidney Disease and Anemia
- ClinicalTrials.gov ID
- NCT05691257
- Acronym / sponsor ID
- JRen
- Conditions
- Heart Failure, Chronic Kidney Diseases, Anemia
- Keywords
- Roxadustat, Anemia, Biomarkers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Roxadustat group | Experimental | Drug: Roxadustat, Drug: Recombinant human eythropoietin and/or Iron agentsRoxadustat group: patients with heart failure and chronic kidney disease and anemia treated with roxadustat and other anemia correction drugs. |
| Control group | Other | Drug: Recombinant human eythropoietin and/or Iron agentsControl 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.) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RoxadustatThe 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. | Drug | Roxadustat group |
| Recombinant human eythropoietin and/or Iron agentsOther drugs to treat anemia include: Recombinant human eythropoietin (RH-EPO), iron agents (ferrous succinate, polysaccharide iron complex, iron sucrose, etc.) | Drug | Control group, Roxadustat group |
Primary outcome
Change in the hemoglobin from baseline
Time frame: up to 8 week
Hemoglobin is calculated by the routine blood test
9 secondary outcomes
Change in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
Time frame: Up to 8 weeks
Change in Left Ventricular Systolic Function
Time frame: Up to 24 weeks
Change in Left Ventricular End-Diastolic Diameter
Time frame: Up to 24 weeks
Change in Left Ventricular Diastolic Function
Time frame: Up to 24 weeks
Change in Low-density lipoprotein（LDL）
Time frame: Up to 8 weeks
Change in Serum ferritin
Time frame: Up to 8 weeks
Change in Transferrin saturation
Time frame: Up to 8 weeks
Change in Left atrial volume
Time frame: Up to 24 weeks
Change in Left atrial volume index
Time frame: Up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiang Liu contact
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Roxadustat and Recombinant human eythropoietin and/or Iron agents in people with Heart Failure and Chronic Kidney Diseases, run by China-Japan Friendship Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mengxi Yang (+8615120049452, mxtezuka@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the hemoglobin from baseline (time frame: up to 8 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2023.