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Comparison Between Darbapoeitin Alpha and Roxadustat in CKD-related Anemia
Sponsor: Ain Shams University
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
Roxadustat
oral hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs)
Darbepoetin Alfa Injection
Traditional injectable darbepoetin alfa
Locations (1)
Electricity Hospital
Cairo, Egypt