Anemia of Chronic Kidney DiseaseNCT05699109
Erythropoiesis Stimulating Agents for Anemia Management in Egyptian Hemodialysis Patients
An observational study of Anemia of Chronic Kidney Disease and Chronic Renal Failure, run by Helwan University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anemia of Chronic Kidney Disease, Chronic Renal Failure, Chronic Renal Failure Anemia
- Type of treatment
- Injection or infusion
- How many people
- 127 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 30 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: Hemodialysis patients that followed the inclusion and exclusion criteria.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Keywords
- Short / Long-acting ESAs, Hemodialysis, Anemia, Chronic renal failure, Pharmacoeconomics
- Medical subject headings
- Kidney Failure, Chronic, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: baseline to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Jan 2021
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Anemia of Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma Magdy Abdelfattah, Helwan University
- Investigators
- Abdel-Hameed Ibrahim Ebid, Professor, Principal investigator, Faculty of Pharmacy, Helwan UniversityAmira Mohamed El-Sawy, Lecturer, Study director, Faculty of Pharmacy, Helwan UniversityHazem Ayoub, Lecturer, Study director, Faculty of Medicine, Al Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05699109
- Sponsor's protocol ID
- Anemia in CKD
- Status last verified
- Jan 2023
- First submitted
- 14 Jan 2023
- Last updated
- 26 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24448756Biggar 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.
PubMed 18397717Sinha 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.
PubMed 30866856Chen 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.
PubMed 35620165Soliman 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.
PubMed 38567102
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Versus Long-Acting Erythropoiesis Stimulating Agents for Anemia Management in Egyptian Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT05699109
- Acronym / sponsor ID
- Anemia in CKD
- Keywords
- Short / Long-acting ESAs, Hemodialysis, Anemia, Chronic renal failure, Pharmacoeconomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Hemodialysis patients that followed the inclusion and exclusion criteria.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Analyze the cost-effectiveness of long-acting (DPO) versus short-acting (EPO) erythropoietin-stimulating agents in hemodialysis patients.
Time frame: baseline to six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Background: PubMed 24448756Bernieh 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.
- Background: PubMed 18397717Biggar 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.
- Background: PubMed 30866856Sinha 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.
- Background: PubMed 35620165Chen 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.
- Derived from this study: PubMed 38567102Soliman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdel-Hameed Ibrahim Ebid, Professor principal investigator
Faculty of Pharmacy, Helwan University
Amira Mohamed El-Sawy, Lecturer study director
Faculty of Pharmacy, Helwan University
Hazem Ayoub, Lecturer study director
Faculty of Medicine, Al Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia of Chronic Kidney Disease and Chronic Renal Failure, run by Helwan University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients reaching the target Hemoglobin in each group. (time frame: baseline to six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05699109, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023; AzTrials last refreshed its copy on 8 Nov 2026.