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

NCT ID: NCT07268807

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2026-09-01

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.

Conditions

Heart Failure; CKD; Anemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

treated with Roxadustat

Roxadustat

Intervention Type: DRUG

treated by Roxadustat

No treated with HIF-PHIs

No interventions assigned to this group

Interventions

Roxadustat

treated by Roxadustat

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhongda Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wenbin Lu

associate chief physician; Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zhongda hospital Southeast University

Nanjing, Jiangsu, China

Countries

China

Central Contacts

Wenbi Lu

Role: CONTACT

101012092@seu.edu.cn

+86 13605185175

Facility Contacts

Wenbi Lu

Role: primary

101012092@seu.edu.cn

+86 13605185175

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan: Version 1.0.1

View Document

Document Type: Study Protocol and Statistical Analysis Plan: Version 1.0.0

View Document

Document Type: Study Protocol and Statistical Analysis Plan: No cover page

View Document

Other Identifiers

2025ZDSYLL380-P01

Identifier Type: -

Identifier Source: org_study_id