" Evaluation of Erythropoietin Therapy in Patients With End-Stage Kidney Disease on Regular Hemodialysis: Hemoglobin Outcomes, and Metabolic Syndrome as a Risk Factor for Erythropoietin Resistance "
1 other identifier
observational
66
0 countries
N/A
Brief Summary
The primary aim of this study is to investigate the association between metabolic syndrome and erythropoietin resistance in patients with End-Stage Kidney Disease (ESKD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2025
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2025
CompletedFirst Posted
Study publicly available on registry
May 21, 2025
CompletedStudy Start
First participant enrolled
June 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2026
CompletedMay 21, 2025
May 1, 2025
6 months
May 14, 2025
May 14, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
HB
Hemoglobin in blood
6 month
Study Arms (2)
group 1
participants with metabolic syndrome
group 2
participants without metabolic syndrome
Interventions
Eligibility Criteria
The patients who will be enrolled in this study are receiving recombinant human erythropoietin therapy with epoetin alfa (αEPO), used to control anemia at our reference hospital.
You may qualify if:
- Patients (and replacements) will be randomly selected by a raffle.
- All participants should be 18 years of age or older and agree to participate in the study after due clarification.
- Patients with end stage kidney disease (ESKD) on regular hemodialysis for more than 3 months.
You may not qualify if:
- \- Patients with neoplasm, severe cardiovascular, cerebrovascular and liver diseases.
- Females with polycystic ovarian syndrome, those on hormonal replacement therapy and pregnant women.
- Patients with infection or autoimmune diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Carney EF. The impact of chronic kidney disease on global health. Nat Rev Nephrol. 2020 May;16(5):251. doi: 10.1038/s41581-020-0268-7. No abstract available.
PMID: 32144399BACKGROUNDEriguchi R, Taniguchi M, Ninomiya T, Hirakata H, Fujimi S, Tsuruya K, Kitazono T. Hyporesponsiveness to erythropoiesis-stimulating agent as a prognostic factor in Japanese hemodialysis patients: the Q-Cohort study. J Nephrol. 2015 Apr;28(2):217-25. doi: 10.1007/s40620-014-0121-9. Epub 2014 Jul 31.
PMID: 25080399BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Teaching Assistant
Study Record Dates
First Submitted
May 14, 2025
First Posted
May 21, 2025
Study Start
June 1, 2025
Primary Completion
December 1, 2025
Study Completion
January 1, 2026
Last Updated
May 21, 2025
Record last verified: 2025-05