Erythropoiesis Stimulating Agents for Anemia Management in Egyptian Hemodialysis Patients

Chronic Renal Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05699109
• Other study ID #: Anemia in CKD
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: September 30, 2021

Study information

• Verified date: January 2023
• Source: Helwan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia
• Anemia of Chronic Kidney Disease
• Chronic Renal Failure
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Egypt	the Memorial Souad Kafafi University Hospital	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Helwan University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View 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. — View 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. — View 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. Erratum In: BMC Nephrol. 2019 Nov 19;20(1):415. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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