Clinical trial NCT05699109: Erythropoiesis Stimulating Agents for Anemia Management in Egyptian Hemodialysis Patients
Official title: Short Versus Long-Acting Erythropoiesis Stimulating Agents for Anemia Management in Egyptian Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia of Chronic Kidney Disease
Chronic Renal Failure
Chronic Renal Failure Anemia
Keywords: Short / Long-acting ESAs
Hemodialysis
Anemia
Chronic renal failure
Pharmacoeconomics
Lead sponsor: Helwan University
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hemodialysis patients that followed the inclusion and exclusion criteria.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of patients reaching the target Hemoglobin in each group.
timeFrame: baseline to six months
Secondary outcomes:
measure: Analyze the cost-effectiveness of long-acting (DPO) versus short-acting (EPO) erythropoietin-stimulating agents in hemodialysis patients.
timeFrame: baseline to six months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: the Memorial Souad Kafafi University Hospital
Study officials:
affiliation: Faculty of Pharmacy, Helwan University
name: Abdel-Hameed Ibrahim Ebid, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Pharmacy, Helwan University
name: Amira Mohamed El-Sawy, Lecturer
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine, Al Azhar University
name: Hazem Ayoub, Lecturer
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.