Prevalence of Erythropoiesis Stimulating Agents Hyporesponsiveness in Dialysis Patients in Assiut University Hospital

NCT ID: NCT06053866

Last Updated: 2024-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-01

Study Completion Date

2025-03-01

Brief Summary

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* The prevalence of erthropoietin stimulating agents hyporesponsiveness in hemodialysis patients in Assiut university hospital
* Assessment of cardiovascular diseases risk in patients with erythropoiesis stimulating agents hyporesponsiveness in hemodialysis patients in Assiut university hospital

Detailed Description

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Anemia is common in patients with chronic kidney disease. The routine use of erthropoietin in anemia control has reduced morbidity and mortality rates in patients with chronic kidney disease. Despite an increase in the use and average dose of recombinant human epoetin over the last 15 years, a substantial percentage of patients still don't achieve hemoglobin targets recommend by international guidelines. The definition of recombinant human epoetin resistance has been introduced to identify those patients in whom the target hemoglobin level is not attained despite a greater than usual dose of erthropoietin stimulating agent. In recent years, increasing attention has been paid to the relationship between dialysis, increased inflammatory stimulus, malnutrition, and erythropoiesis stimulating agents response. Erythropoiesis stimulating agents hyporesponsiveness was defined by the erythropoietin resistance index, which was the erythropoietin dose per week divided by body weight and Hemoglobin level . The resistance to erythropoiesis stimulating agents is directly related with incident comorbidity in patients on hemodialysis and it can be interpreted as a useful marker of early mortality. Patients with higher erythropoietin resistance index values had a higher all cause mortality rate and cardiovascular mortality rate. Erythropoietin resistance index was related with left ventricular mass index, left ventricle systolic function and cardiovascular events in patients with hemodialysis. By monitoring of erthropoietin resistance index, early identification of the epoetin resistance may be useful to predict the cardiovascular risk in hemodialysis patients

Conditions

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Erythropoietin Resistant Anemia (EPO Resistant Anemia)

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* age more than 18
* End stage renal disease patients undergoing regular hemodialysis in Assiut University Hospital - Hemodialysis unit for duration at least 3 months

Exclusion Criteria

* acute infectious disease within one month
* active liver disease or cancer
* recent blood transfusion or surgical intervention
* active bleeding or hemorrhage
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Feby Rasmy Khalifa Makar

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hewida Abdelhakem Nafady

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Radwa Awad abdelhafez

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

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Feby Rasmy Khalifa

Role: CONTACT

+201015508087

References

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de Lurdes Agostinho Cabrita A, Pinho A, Malho A, Morgado E, Faisca M, Carrasqueira H, Silva AP, Neves PL. Risk factors for high erythropoiesis stimulating agent resistance index in pre-dialysis chronic kidney disease patients, stages 4 and 5. Int Urol Nephrol. 2011 Sep;43(3):835-40. doi: 10.1007/s11255-010-9805-9. Epub 2010 Jul 17.

Reference Type BACKGROUND
PMID: 20640598 (View on PubMed)

Bamgbola OF, Kaskel FJ, Coco M. Analyses of age, gender and other risk factors of erythropoietin resistance in pediatric and adult dialysis cohorts. Pediatr Nephrol. 2009 Mar;24(3):571-9. doi: 10.1007/s00467-008-0954-3. Epub 2008 Sep 18.

Reference Type BACKGROUND
PMID: 18800231 (View on PubMed)

Del Vecchio L, Pozzoni P, Andrulli S, Locatelli F. Inflammation and resistance to treatment with recombinant human erythropoietin. J Ren Nutr. 2005 Jan;15(1):137-41. doi: 10.1053/j.jrn.2004.09.024.

Reference Type BACKGROUND
PMID: 15648023 (View on PubMed)

Tanaka S, Kitamura H, Tsuruya K, Kitazono T, Nakano T; FKR Study Collaboration Group. Prevalence, treatment status, and predictors of anemia and erythropoietin hyporesponsiveness in Japanese patients with non-dialysis-dependent chronic kidney disease: a cross-sectional study. Clin Exp Nephrol. 2022 Sep;26(9):867-879. doi: 10.1007/s10157-022-02227-8. Epub 2022 May 4.

Reference Type BACKGROUND
PMID: 35507237 (View on PubMed)

Okazaki M, Komatsu M, Kawaguchi H, Tsuchiya K, Nitta K. Erythropoietin resistance index and the all-cause mortality of chronic hemodialysis patients. Blood Purif. 2014;37(2):106-12. doi: 10.1159/000358215. Epub 2014 Mar 5.

Reference Type BACKGROUND
PMID: 24603656 (View on PubMed)

Lopez-Gomez JM, Portoles JM, Aljama P. Factors that condition the response to erythropoietin in patients on hemodialysis and their relation to mortality. Kidney Int Suppl. 2008 Dec;(111):S75-81. doi: 10.1038/ki.2008.523.

Reference Type BACKGROUND
PMID: 19034333 (View on PubMed)

Lu X, Zhang J, Wang S, Yu Q, Li H. High Erythropoiesis Resistance Index Is a Significant Predictor of Cardiovascular and All-Cause Mortality in Chinese Maintenance Hemodialysis Patients. Mediators Inflamm. 2020 Nov 26;2020:1027230. doi: 10.1155/2020/1027230. eCollection 2020.

Reference Type BACKGROUND
PMID: 33293895 (View on PubMed)

Chung S, Song HC, Shin SJ, Ihm SH, Park CS, Kim HY, Yang CW, Kim YS, Choi EJ, Kim YK. Relationship between erythropoietin resistance index and left ventricular mass and function and cardiovascular events in patients on chronic hemodialysis. Hemodial Int. 2012 Apr;16(2):181-7. doi: 10.1111/j.1542-4758.2011.00644.x.

Reference Type BACKGROUND
PMID: 22103889 (View on PubMed)

Other Identifiers

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Erythropoietin resistance

Identifier Type: -

Identifier Source: org_study_id

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