Erythropoiesis Stimulating Agents for Anemia Management in Egyptian Hemodialysis Patients

NCT05699109 | Completed

• 1 other identifier: Anemia in CKD
• Study Type: observational
• Target: 127
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study aims to compare long-acting darbepoetin alpha versus short-acting epoetin alpha erythropoietin-stimulating agents in Egyptian hemodialysis patients. The main questions aim to answer are:

• What are the effectiveness and safety of long- acting versus short-acting erythropoietin-stimulating agents in Egyptian hemodialysis patients?
• What is the cost-effectiveness of long- acting versus short-acting erythropoietin-stimulating agents in Egyptian hemodialysis patients? Participants will be divided into 2 groups; epoetin alfa (short-acting ESA), Eprex group, and darbepoetin alfa (long-acting ESA), Aranesp group for six month study period.

Conditions

Anemia of Chronic Kidney Disease; Chronic Renal Failure; Chronic Renal Failure Anemia

Keywords

Short / Long-acting ESAs; Hemodialysis; Anemia; Chronic renal failure; Pharmacoeconomics

Outcome Measures

Primary Outcomes (1)

• Percentage of patients reaching the target Hemoglobin in each group.

  Assess the percentage of patients reaching the target Hemoglobin (10-11.5 g/dl) in each group during the study period.

  baseline to six months

Secondary Outcomes (1)

• Analyze the cost-effectiveness of long-acting (DPO) versus short-acting (EPO) erythropoietin-stimulating agents in hemodialysis patients.

  baseline to six months

Study Arms (2)

Aranesp group

Aranesp group: patients received darbepoetin alpha prefilled syringe subcutaneously once weekly or biweekly

Eprex group

Eprex group: patients received epoetin alpha prefilled syringe subcutaneously one to three times per week

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hemodialysis patients that followed the inclusion and exclusion criteria.

You may qualify if:

• Patients who have been stable and undergoing hemodialysis three times per week for at least three months
• Age must be 18 or older
• Patients who had been receiving a single form of ESA treatment for at least three months before the study's launch.

You may not qualify if:

• altered the type of ESA therapy; 2) underwent significant surgery; or (3) received RBC transfusions
• failed to adhere to dialysis therapy, as shown by missing more than two appointments each month.
• have COVID-19 infection.
• had cancer.
• underwent a kidney transplant
• were pregnant or nursing mothers
• were not followed up for the full six-month research period.

Sponsors & Collaborators

• Helwan University: lead

Study Sites (1)

the Memorial Souad Kafafi University Hospital

Giza, Egypt

Location

Related Publications (5)

• Bernieh B, Abouchacra S, Boobes Y, Al Hakim MR, Nagelkerke N, Chaaban A, Ahmed M, Hussain Q, Jack HE, Abayechi F, Khan I, Gebran N. Comparison between short- and long-acting erythropoiesis-stimulating agents in hemodialysis patients: target hemoglobin, variability, and outcome. Int Urol Nephrol. 2014 Feb;46(2):453-9. doi: 10.1007/s11255-013-0640-7. Epub 2014 Jan 22.

  PMID: 24448756 BACKGROUND

• Biggar P, Ketteler M, Hennemann H, Domling R. Switch of ESA therapy from darbepoetin-alpha to epoetin-beta in hemodialysis patients: a single-center experience. Clin Nephrol. 2008 Mar;69(3):185-92. doi: 10.5414/cnp69185.

  PMID: 18397717 BACKGROUND

• Sinha SD, Bandi VK, Bheemareddy BR, Thakur P, Chary S, Mehta K, Pinnamareddy VR, Pandey R, Sreepada S, Durugkar S. Efficacy, tolerability and safety of darbepoetin alfa injection for the treatment of anemia associated with chronic kidney disease (CKD) undergoing dialysis: a randomized, phase-III trial. BMC Nephrol. 2019 Mar 13;20(1):90. doi: 10.1186/s12882-019-1209-1.

  PMID: 30866856 BACKGROUND

• Chen N, Xing C, Niu J, Liu B, Fu J, Zhao J, Ni Z, Wang M, Liu W, Zhao J, Zhong L, Wu X, Li W, Chen Y, Shi W, Chen J, Yin A, Fu P, Wang R, Jiang G, Hou F, Ding G, Chen J, Xu G, Kondo Y, Su Y, Mei C. Darbepoetin alfa injection versus epoetin alfa injection for treating anemia of Chinese hemodialysis patients with chronic kidney failure: A randomized, open-label, parallel-group, non-inferiority Phase III trail. Chronic Dis Transl Med. 2022 Mar 29;8(1):59-70. doi: 10.1002/cdt3.13. eCollection 2022 Mar.

  PMID: 35620165 BACKGROUND

• Soliman AE, Magdy S, Ayoub HS, Ebid AI. Short versus long-acting erythropoiesis-stimulating agents for anemia management in Egyptian hemodialysis patients. Qatar Med J. 2024 Mar 11;2024(1):16. doi: 10.5339/qmj.2024.16. eCollection 2024.

  PMID: 38567102 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic; Anemia

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Abdel-Hameed Ibrahim Ebid, Professor

  Faculty of Pharmacy, Helwan University

  PRINCIPAL INVESTIGATOR

• Amira Mohamed El-Sawy, Lecturer

  Faculty of Pharmacy, Helwan University

  STUDY DIRECTOR

• Hazem Ayoub, Lecturer

  Faculty of Medicine, Al Azhar University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant

Study Record Dates

• First Submitted: January 14, 2023
• First Posted: January 26, 2023
• Study Start: January 1, 2021
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)