Comparison Between Darbapoeitin Alpha and Roxadustat in CKD-related Anemia

April 2, 2026 updated by: Ain Shams University

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Electricity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Egyptian patients with ESKD- or HD-related anemia who follow up at the Electricity hospital.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Darbepoeitin Alpha
Patients are treated with the traditional injectable darbepoetin alfa
Roxadustat
Patients are treated with the oral hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kidney Functions
Time Frame: 12 weeks
The study compares the changes in serum creatinine in patients taking roxadustat in comparison to darbepoetin alfa
12 weeks
Change in hemoglobin levels
Time Frame: 12 weeks
Hemoglobin levels are measured at baseline and at the end of the 12 weeks
12 weeks
RBC transfusion rate
Time Frame: 12 weeks
12 weeks
The need of IV iron
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Collaborators

Misr International University
October 6 University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Actual)

June 12, 2025

Study Completion (Actual)

June 12, 2025

Study Registration Dates

First Submitted

April 2, 2026

First Submitted That Met QC Criteria

April 2, 2026

First Posted (Actual)

April 8, 2026

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9-2025/18

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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