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OpenTrials
Completed

NCT Number: NCT07517744

Comparison Between Darbapoeitin Alpha and Roxadustat in CKD-related Anemia

Anemia is a common and debilitating complication of end-stage kidney disease (ESKD) that is associated with reduced quality of life and high morbidity and mortality. ESKD-related anemia is associated with many adverse comorbidities and outcomes; however, normalizing the levels of hemoglobin proved to be insignificant in improving most adverse outcomes. This study aims to evaluate the real-world effectiveness and safety of an ESA and a HIF-PHI in patients with CKD-related anemia.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Electricity Hospital

Cairo, Egypt

About this study

Anemia is a common and debilitating complication of chronic kidney disease (CKD), affecting a significant proportion of patients worldwide. It is approximately twice as prevalent among ESKD patients compared to the general population. The prevalence of anemia increases across the advancing stages of CKD, with estimates anywhere from 7% to >50%. Study Design:

This prospective observational cohort study involved 35 hemodialysis patients at Electricity Hospital, Almaza, Cairo, who were randomly treated with either Roxadustat or Darbepoetin Alfa over 12 weeks. The study aims to assess whether Roxadustat use in the management of ESKD-related anemia results in improved iron profile and reduced iron needs compared with traditional treatment for ESKD-related anemia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • End-stage kidney disease-related anemia
  • Hemodialysis-related anemia
  • The mean of the two most recent Hemoglobin values before randomization was 10.5mg/dL or less

Exclusion criteria

  • ESA treatment 12 weeks before transfusion
  • RBC transfusion 8 weeks before transfusion
  • IV iron transfusion 6 weeks before transfusion
  • Known history of myelodysplastic syndrome
  • Known history of multiple myeloma
  • Known history of hereditary hematologic diseases
  • Active bleeding or any cause of anemia unrelated to CKD
  • NYHA Class III or IV congestive heart failure
  • Liver disease, defined as ALT or AST 3x ULN or greater, or total bilirubin 1.5x ULN or greater
  • Prior organ transplant

Treatment and study plan

Primary outcomes

  1. Change in Iron profile

    Time frame: 12 weeks

    The study aims to assess whether Roxadustat usage in the management of CKD-related anemia results in improving iron profile and reducing iron needs compared with traditional treatment for CKD-related anemia.

Secondary outcomes

  1. Kidney Functions

    Time frame: 12 weeks

    The study compares the changes in serum creatinine in patients taking roxadustat in comparison to darbepoetin alfa

  2. Change in hemoglobin levels

    Time frame: 12 weeks

    Hemoglobin levels are measured at baseline and at the end of the 12 weeks

  3. RBC transfusion rate

    Time frame: 12 weeks

  4. The need of IV iron

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Collaborators

  • Misr International University
  • October 6 University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 8, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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