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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline to six months |
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Inclusion Criteria:
Exclusion Criteria:
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Hemodialysis patients that followed the inclusion and exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Memorial Souad Kafafi University Hospital | Giza | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24448756 | Background | 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. | |
| 18397717 |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| 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. |
| 30866856 | 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. |
| 35620165 | 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. |
| 38567102 | Derived | 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. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |