Comparison Between Darbapoeitin Alpha and Roxadustat in CKD-related Anemia

NCT07517744 | Completed

• 1 other identifier: 9-2025/18
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

CKD Anemia; CKD Anemia in Stable Dialysis Patients

Keywords

roxadustat; anemia; CKD-related Anemia; Darbepoeitin Alpha

Outcome Measures

Primary Outcomes (1)

• Change in Iron profile

  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 Outcomes (4)

• Kidney Functions

  12 weeks

• Change in hemoglobin levels

  12 weeks

• RBC transfusion rate

  12 weeks

• The need of IV iron

  12 weeks

Study Arms (2)

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)

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead
• Misr International University: collaborator
• October 6 University: collaborator

Study Sites (1)

Electricity Hospital

Cairo, Egypt

Location

Related Publications (2)

• Batchelor EK, Kapitsinou P, Pergola PE, Kovesdy CP, Jalal DI. Iron Deficiency in Chronic Kidney Disease: Updates on Pathophysiology, Diagnosis, and Treatment. J Am Soc Nephrol. 2020 Mar;31(3):456-468. doi: 10.1681/ASN.2019020213. Epub 2020 Feb 10.

  PMID: 32041774 BACKGROUND

• Stoumpos S, Crowe K, Sarafidis P, Barratt J, Bolignano D, Del Vecchio L, Malyszko J, Wiecek A, Ortiz A, Cozzolino M. Hypoxia-inducible factor prolyl hydroxylase inhibitors for anaemia in chronic kidney disease: a clinical practice document by the European Renal Best Practice board of the European Renal Association. Nephrol Dial Transplant. 2024 Sep 27;39(10):1710-1730. doi: 10.1093/ndt/gfae075.

  PMID: 38573822 BACKGROUND

Related Links

• KDIGO Clinical Practice Guideline for Anemia in Chronic Kidney Disease

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 8, 2026
• Study Start: June 1, 2024
• Primary Completion: June 12, 2025
• Study Completion: June 12, 2025
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

EG (1)