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COMPLETED
NCT07517744

Comparison Between Darbapoeitin Alpha and Roxadustat in CKD-related Anemia

Sponsor: Ain Shams University

View on ClinicalTrials.gov

Summary

The goal of this prospective cohort clinical trial is to compare the effects of roxadustat and darbepoetin alfa on hematological and iron-related parameters in adults with end-stage kidney disease (ESKD) receiving maintenance hemodialysis who have erythropoietin-resistant anemia. The main questions it aims to answer are: * Do hematological and iron-related parameters change following treatment with roxadustat or darbepoetin alfa? * Are there differences in treatment response between roxadustat and darbepoetin alfa? Researchers will compare oral roxadustat with subcutaneous darbepoetin alfa to evaluate changes in hematological and iron-related parameters over 12 weeks. Researchers investigate patients who: * Receive either roxadustat 70 mg orally three times weekly or darbepoetin alfa subcutaneously according to one of two permitted weight-based dosing regimens. * Undergo laboratory assessments at baseline and after 12 weeks of treatment, including hemoglobin, red blood cell indices, and iron-related parameters.

Official title: Roxadustat Versus Darbepoetin Alfa on Iron Repletion Effects in the Management of Anemia in Hemodialysis Patients

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

66

Start Date

2026-04-15

Completion Date

2026-10-10

Last Updated

2026-10-28

Healthy Volunteers

No

Interventions

DRUG

Roxadustat

oral hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs)

DRUG

Darbepoetin Alfa Injection

Traditional injectable darbepoetin alfa

Locations (1)

Electricity Hospital

Cairo, Egypt