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Status unknownNCT05312346Updated Apr 5, 2022

Factors Predicting Erythropoietin Responsiveness in Children on Hemodialysis at Sohag University Hospital

An observational study in Pediatric Patients on Hemodialysis, sponsored by Sohag University. Status unknown at 1 site in Egypt. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2022-04-05.

Sponsored by Sohag University · Observational

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
1 Year and older
Sex
All
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Study summary

Anemia is common in patients on hemodialysis (HD) due to lack of erythropoietin (EPO) synthesis and iron deficiency is occurring in HD patients due to chronic blood loss through the dialysis circuit, repeated blood sampling, shortened red blood cell life span and lack of adherence to treatment .

Anemia is one of the most important complications that affects morbidity and mortality in chronic kidney disease (CKD) patients. It has significant impacts on those patients such as fatigue, weakness, shortness of breath, decreased quality of life, exercise capacity and physical activity, growth retardation and decreased cognitive functions, left ventricular hypertrophy, and congestive heart failure So, proper management of anemia is very important .

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Conditions studied

  • Pediatric Patients on Hemodialysis
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In context

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Year and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

These children are attending in our Pediatric dialysis unit at Sohag University Hospital, Egypt between April 2022 and April 2023.

Inclusion criteria

  • (1) patients started dialysis in the age range of 1-18years. (2) Patient will be on regular hemodialysis.

Exclusion criteria

Exclusion Criteria:

  • Children who have no other co existent hematological disorder .
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • responsiveness to erythropoietin stimulating agent

    we evolute responsiveness of patients on hemodialysis for erythropoietin stimulating agents or not and factors effecting this response

    Diagnostic Test: seum zinic,vit B12, parathyriod function

Interventions

  • Diagnostic testseum zinic,vit B12, parathyriod function

    seum zinic,vit B12, parathyriod function

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What researchers measure

Primary outcomes

  1. Hb g/dl

    measure hemoglobin level

    Time frame: one year

  2. Iron profile

    measure iron profile on blood

    Time frame: one year

  3. Serum creatinine

    serum creatinine

    Time frame: one year

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Study locations

1 site
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References and documents

Publications

  • Allali S, Brousse V, Sacri AS, Chalumeau M, de Montalembert M. Anemia in children: prevalence, causes, diagnostic work-up, and long-term consequences. Expert Rev Hematol. 2017 Nov;10(11):1023-1028. doi: 10.1080/17474086.2017.1354696. Epub 2017 Oct 12. PubMed 29023171 ↗
  • Mikhail A, Brown C, Williams JA, Mathrani V, Shrivastava R, Evans J, Isaac H, Bhandari S. Renal association clinical practice guideline on Anaemia of Chronic Kidney Disease. BMC Nephrol. 2017 Nov 30;18(1):345. doi: 10.1186/s12882-017-0688-1. PubMed 29191165 ↗
  • Bamgbola OF. Pattern of resistance to erythropoietin-stimulating agents in chronic kidney disease. Kidney Int. 2011 Sep;80(5):464-74. doi: 10.1038/ki.2011.179. Epub 2011 Jun 22. PubMed 21697809 ↗
  • Akbari A, Clase CM, Acott P, Battistella M, Bello A, Feltmate P, Grill A, Karsanji M, Komenda P, Madore F, Manns BJ, Mahdavi S, Mustafa RA, Smyth A, Welcher ES. Canadian Society of Nephrology commentary on the KDIGO clinical practice guideline for CKD evaluation and management. Am J Kidney Dis. 2015 Feb;65(2):177-205. doi: 10.1053/j.ajkd.2014.10.013. Epub 2014 Nov 4. PubMed 25511161 ↗

Individual participant data

Plan to share: Yes

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05312346
Lead sponsor
Sohag University
Responsible party
Hanan Nagdy Fawzy (pediatric specialist, Sohag University) — Principal investigator
First posted
Apr 5, 2022
Start date
Apr 1, 2022 (estimated)
Primary completion
Apr 1, 2023 (estimated)
Completion
Apr 1, 2023 (estimated)
Last update
Apr 5, 2022

Study contacts

hanan N fawzi, specialist
Contact
hanan_nagdy_post@med.sohag.edu.eg
01009351849
Alzahraa A Ahmed, professor
Contact

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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