Heart FailureNCT07268807
Effect of Roxadustat on Heart Failure Patients With Anaemia and Moderate-to-Severe Chronic Kidney Disease
An observational study of Heart Failure and CKD, run by Zhongda Hospital at 1 site in China.
Trial summary
Previous clinical observations of potential benefit from Roxadustat in this complex patient population prompted this investigation Therefore, the investigators designed this retrospective, observational study to thoroughly investigate the effects of Roxadustat on heart failure treatment and ventricular remodelling in… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Failure, CKD, Anemia
- What is being tested?
- Roxadustat
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 1 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Heart Failure Patients with Anaemia and Moderate-to-Severe Chronic Kidney Disease
Who may be able to join
- aged 18-85 years, regardless of gender;
- fulfilled the diagnostic criteria for heart failure and chronic kidney disease;
- haemoglobin level <130 g/L for men or <120 g/L for women at baseline;
- had regularly received Roxadustat for over one year;
- possessed complete clinical data, including information from pre-specified time points.
Who cannot join
- comorbid myelodysplastic syndromes, multiple myeloma, hereditary hematologic diseases (e.g., thalassemia, sickle cell anaemia, pure red cell aplasia), hemosiderosis, hemochromatosis, or other disorders confirmed to cause anaemia due to erythrocyte destruction and/or abnormal hematopoietic function;
- haemoglobin level ≤45 g/L on two or more blood tests, a history of major bleeding within one year, or a history of anaemia corrected by blood transfusion;
- bilateral nephrectomy, kidney transplantation within ≤6 months, or congenital kidney diseases (e.g., polycystic kidney disease);
- hypertrophic obstructive cardiomyopathy or congenital heart disease with right-to-left shunt;
- comorbid malignancy with an investigator-assessed life expectancy of less than 12 months;
- pregnancy or lactation;
- known allergy to the study drug (active ingredient or excipients);
- participation in a drug clinical trial within one year.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongda hospital Southeast University
Nanjing, Jiangsu, 210000
Wenbi Lu, +86 13605185175, 101012092@seu.edu.cn
About this study
Official title: Effect of Roxadustat on Heart Failure Patients With Anaemia and Moderate-to-Severe Chronic Kidney Disease: A Single-Centre Retrospective Study
Previous clinical observations of potential benefit from Roxadustat in this complex patient population prompted this investigation Therefore, the investigators designed this retrospective, observational study to thoroughly investigate the effects of Roxadustat on heart failure treatment and ventricular remodelling in this specific patient population, aiming to provide new insights for patients management.
- Conditions
- Heart Failure, CKD, Anemia
- Being tested
- Roxadustat
- Medical subject headings
- Heart Failure, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RoxadustatDrug
treated by Roxadustat
| Study group | Role | What they receive |
|---|---|---|
| treated with Roxadustat | Not described Receives: Drug: Roxadustat | |
| No treated with HIF-PHIs | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mace
MACE was defined as the occurrence of any of the following: all-cause mortality, hospitalization for unstable angina or coronary revascularization, heart failure rehospitalization, or ischemic stroke.
Measured: 1 year
BNP
B-type natriuretic peptide
Measured: 1 year
NYHA functional classification
I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath.
II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain.
III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain.
IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort.
Measured: 1 year
left ventricular ejection fraction (LVEF)
Measured: 1 year
left ventricular end-diastolic dimension (LVEDD)
Measured: 1 year
interventricular septal thickness (IVS)
Measured: 1 year
left ventricular posterior wall thickness (LVPW)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenbin Lu, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07268807
- Sponsor's protocol ID
- 2025ZDSYLL380-P01
- Status last verified
- Sep 2025
- First submitted
- 14 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No application for disclosure has been submitted to the Clinical Ethics Committee.
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Roxadustat on Heart Failure Patients With Anaemia and Moderate-to-Severe Chronic Kidney Disease: A Single-Centre Retrospective Study
- ClinicalTrials.gov ID
- NCT07268807
- Acronym / sponsor ID
- 2025ZDSYLL380-P01
- Conditions
- Heart Failure, CKD, Anemia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 8 Dec 2025 (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.
Previous clinical observations of potential benefit from Roxadustat in this complex patient population prompted this investigation Therefore, the investigators designed this retrospective, observational study to thoroughly investigate the effects of Roxadustat on heart failure treatment and ventricular remodelling in this specific patient population, aiming to provide new insights for patients management.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treated with Roxadustat | – | Drug: Roxadustat |
| No treated with HIF-PHIs | – | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Heart Failure Patients with Anaemia and Moderate-to-Severe Chronic Kidney Disease
Key inclusion criteria (5 listed)
- aged 18-85 years, regardless of gender;
- fulfilled the diagnostic criteria for heart failure and chronic kidney disease;
- haemoglobin level <130 g/L for men or <120 g/L for women at baseline;
- had regularly received Roxadustat for over one year;
- possessed complete clinical data, including information from pre-specified time points.
Key exclusion criteria (8 listed)
- comorbid myelodysplastic syndromes, multiple myeloma, hereditary hematologic diseases (e.g., thalassemia, sickle cell anaemia, pure red cell aplasia), hemosiderosis, hemochromatosis, or other disorders confirmed to cause anaemia due to erythrocyte destruction and/or abnormal hematopoietic function;
- haemoglobin level ≤45 g/L on two or more blood tests, a history of major bleeding within one year, or a history of anaemia corrected by blood transfusion;
- bilateral nephrectomy, kidney transplantation within ≤6 months, or congenital kidney diseases (e.g., polycystic kidney disease);
- hypertrophic obstructive cardiomyopathy or congenital heart disease with right-to-left shunt;
- comorbid malignancy with an investigator-assessed life expectancy of less than 12 months;
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 |
|---|---|---|
| Roxadustattreated by Roxadustat | Drug | treated with Roxadustat |
Primary outcome
Mace
Time frame: 1 year
MACE was defined as the occurrence of any of the following: all-cause mortality, hospitalization for unstable angina or coronary revascularization, heart failure rehospitalization, or ischemic stroke.
BNP
Time frame: 1 year
B-type natriuretic peptide
NYHA functional classification
Time frame: 1 year
I: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. II: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. III: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. IV: Symptoms of heart failure at rest. Any physical activity causes further discomfort.
left ventricular ejection fraction (LVEF)
Time frame: 1 year
left ventricular end-diastolic dimension (LVEDD)
Time frame: 1 year
interventricular septal thickness (IVS)
Time frame: 1 year
left ventricular posterior wall thickness (LVPW)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: Undecided. No application for disclosure has been submitted to the Clinical Ethics Committee.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and CKD, run by Zhongda Hospital at 1 site in China.
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 5 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: opening soon, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenbi Lu (+86 13605185175, 101012092@seu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mace (time frame: 1 year). The study lists 7 primary outcomes in all. 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 8 Dec 2025.