Erythropoiesis Stimulating Agents for Anemia Management in Egyptian Hemodialysis Patients

Sponsor

Helwan University (Other)

Overall Status

Completed

CT.gov ID

NCT05699109

Collaborator

(none)

127

Enrollment

Location

8.9

Actual Duration (Months)

14.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anemia of Chronic Kidney Disease Chronic Renal Failure Chronic Renal Failure Anemia

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 Design

Study Type:

Observational

Actual Enrollment :

127 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2021

Actual Primary Completion Date :

Sep 30, 2021

Actual Study Completion Date :

Sep 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	the Memorial Souad Kafafi University Hospital	Giza		Egypt

Sponsors and Collaborators

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