NCT06053866

Brief Summary

  • 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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2024

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 26, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

1 year

First QC Date

September 13, 2023

Last Update Submit

January 29, 2024

Conditions

Erythropoietin Resistant Anemia (EPO Resistant Anemia)

Outcome Measures

Primary Outcomes (1)

  • Assessment of the prevalence of Erythropoiesis stimulating agents hyporesponsiveness in dialysis patients in Assiut university hospital

    Erythropoiesis resistance index which is the erythropoietin dose per week divided by body weight and Hemoglobin level

    One year

Secondary Outcomes (1)

  • Assessment of cardiovascular diseases risk in hemodialysis patients with erythropoiesis stimulating agents hyporesponsiveness

    One year

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

End stage renal disease patients undergoing regular hemodialysis for at least 3 months duration

You may qualify if:

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

You may not qualify if:

  • acute infectious disease within one month
  • active liver disease or cancer
  • recent blood transfusion or surgical intervention
  • active bleeding or hemorrhage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • 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.

    PMID: 20640598BACKGROUND

  • 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.

    PMID: 18800231BACKGROUND

  • 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.

    PMID: 15648023BACKGROUND

  • 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.

    PMID: 35507237BACKGROUND

  • 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.

    PMID: 24603656BACKGROUND

  • 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.

    PMID: 19034333BACKGROUND

  • 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.

    PMID: 33293895BACKGROUND

  • 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.

    PMID: 22103889BACKGROUND

Study Officials

  • Hewida Abdelhakem Nafady

    Assiut University

    PRINCIPAL INVESTIGATOR

  • Radwa Awad abdelhafez

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Feby Rasmy Khalifa

CONTACT

+201015508087fybyrsmy@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

September 13, 2023

First Posted

September 26, 2023

Study Start

February 1, 2024

Primary Completion

February 1, 2025

Study Completion

March 1, 2025

Last Updated

January 31, 2024

Record last verified: 2024-01