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Effect of Roxadustat on Heart Failure Patients With Anaemia and Moderate-to-Severe Chronic Kidney Disease

Effect of Roxadustat on Heart Failure Patients With Anaemia and Moderate-to-Severe Chronic Kidney Disease: A Single-Centre Retrospective Study

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07268807
Enrollment
200
Registered
2025-12-08
Start date
2025-12-01
Completion date
2026-09-01
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, CKD, Heart Failure

Brief 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 this specific patient population, aiming to provide new insights for patients management.

Interventions

DRUGRoxadustat

treated by Roxadustat

Sponsors

Zhongda Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Mace1 yearMACE 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.
BNP1 yearB-type natriuretic peptide
NYHA functional classification1 yearI: 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)1 year
left ventricular end-diastolic dimension (LVEDD)1 year
interventricular septal thickness (IVS)1 year
left ventricular posterior wall thickness (LVPW)1 year

Countries

China

Contacts

Primary ContactWenbi Lu
101012092@seu.edu.cn+86 13605185175

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026