Erythropoiesis Stimulating Agents for Anemia Management in Egyptian Hemodialysis Patients

January 24, 2023 updated by: Salma Magdy Abdelfattah, Helwan University

Short Versus Long-Acting Erythropoiesis Stimulating Agents for Anemia Management in Egyptian Hemodialysis Patients

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Anemia, the most prevalent and dangerous complication of chronic kidney disease, is caused when the kidney is unable to produce enough erythropoietin to promote the creation of red blood cells (CKD). Anemia from CKD is linked to higher mortality, cardiovascular disease, exhaustion, dyspnea, and a lower quality of life for patients.

It has been demonstrated that using erythropoietin-stimulating drugs (ESAs) in treating renal anemia increases survival, lowers cardiovascular morbidity, and improves the quality of life.

Epoetin alfa (EPO), an ESA with a shorter half-life, and darbepoetin alfa (DPO), are the two ESAs used in hemodialysis centers the most frequently in Egypt (longer half life ) Epoetin alfa is dosed one to three times per week, whereas darbepoetin alfa is dosed once per week or every two weeks.

Compared to epoetins, darbepoetin alfa's extended dose interval may benefit patients and their medical professionals.

Despite the fact that ESAs save CKD patients from needing blood transfusions, clinical trials, meta-analyses, and mortality hazards with ESAs targeting high hemoglobin levels have been shown. A higher ESA dose may be linked to cardiovascular problems and all-cause mortality independent of hemoglobin level.

Darbepoetin alfa has a lower risk of side effects because it only requires 35% of the dosage of epoetin alfa to attain the same target hemoglobin level. Darbepoetin alfa also has an advantage over epoetin alfa in that it makes it easier for the body to mobilize iron into the bone marrow to cause successful erythropoiesis, which may shield the body from any potential negative effects from having too much iron stored there. Despite this, the medication that Egyptian hemodialysis centers use the most is (EPO). This study compares (DPO) and (EPO) to determine which should be utilized based on efficacy, safety, and cost.

Study Type

Observational

Enrollment (Actual)

127

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
      • Giza, Egypt
        • the Memorial Souad Kafafi University 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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hemodialysis patients that followed the inclusion and exclusion criteria.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients reaching the target Hemoglobin in each group.
Time Frame: baseline to six months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analyze the cost-effectiveness of long-acting (DPO) versus short-acting (EPO) erythropoietin-stimulating agents in hemodialysis patients.
Time Frame: baseline to six months
Determine which of the 2 regimen groups is the cost-saving regimen by the cost-effectiveness analysis to examine both the costs and health outcomes of long-acting (DPO) versus short-acting (EPO) erythropoietin-stimulating agents in hemodialysis patients.
baseline to six months

Collaborators and Investigators

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

Sponsor

Helwan University

Investigators

  • Principal Investigator: Abdel-Hameed Ibrahim Ebid, Professor, Faculty of pharmacy, Helwan university
  • Study Director: Amira Mohamed El-Sawy, Lecturer, Faculty of pharmacy, Helwan university
  • Study Director: Hazem Ayoub, Lecturer, Faculty of Medicine, Al Azhar 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

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)

January 1, 2021

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

January 14, 2023

First Submitted That Met QC Criteria

January 24, 2023

First Posted (Estimate)

January 26, 2023

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 24, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Anemia in CKD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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