Pediatric Patients on HemodialysisNCT05312346
Factors Predicting Erythropoietin Responsiveness in Children on Hemodialysis at Sohag University Hospital
An observational study of Pediatric Patients on Hemodialysis, run by Sohag University at 1 site in Egypt.
Trial 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 . Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Pediatric Patients on Hemodialysis
- What is being tested?
- seum zinic,vit B12, parathyriod function
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 1 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: These children are attending in our Pediatric dialysis unit at Sohag University Hospital, Egypt between April 2022 and April 2023.
Who may be able to join
- (1) patients started dialysis in the age range of 1-18years. (2) Patient will be on regular hemodialysis.
Who cannot join
- Children who have no other co existent hematological disorder .
Trial locations and contacts
1 site in 1 country.
Alzahraa A Ahmed, professor contact
Egypt1 site
Sohag University Hospital
Sohag
Osama R ElSherif, professor, portal@med.sohag.edu.eg
About this study
Official title: University Hospital
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 .
- Conditions
- Pediatric Patients on Hemodialysis
- Being tested
- seum zinic,vit B12, parathyriod function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
seum zinic,vit B12, parathyriod functionDiagnostic test
seum zinic,vit B12, parathyriod function
| Study group | Role | What they receive |
|---|---|---|
| responsiveness to erythropoietin stimulating agent | we evolute responsiveness of patients on hemodialysis for erythropoietin stimulating agents or not and factors effecting this response Receives: Diagnostic Test: seum zinic,vit B12, parathyriod function |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hb g/dl
measure hemoglobin level
Measured: one year
Iron profile
measure iron profile on blood
Measured: one year
Serum creatinine
serum creatinine
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start1 Apr 2022 (estimated)
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pediatric Patients on HemodialysisStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanan Nagdy Fawzy, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05312346
- Sponsor's protocol ID
- Soh-Med-22-03-04
- Status last verified
- Mar 2022
- First submitted
- 14 Mar 2022
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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 29023171Mikhail 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 29191165Bamgbola 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 21697809Akbari 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- University Hospital
- ClinicalTrials.gov ID
- NCT05312346
- Acronym / sponsor ID
- Soh-Med-22-03-04
- Conditions
- Pediatric Patients on Hemodialysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 5 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| responsiveness to erythropoietin stimulating agent | – | Diagnostic Test: seum zinic,vit B12, parathyriod functionwe evolute responsiveness of patients on hemodialysis for erythropoietin stimulating agents or not and factors effecting this response |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- These children are attending in our Pediatric dialysis unit at Sohag University Hospital, Egypt between April 2022 and April 2023.
Key inclusion criteria (1 listed)
- (1) patients started dialysis in the age range of 1-18years. (2) Patient will be on regular hemodialysis.
Key exclusion criteria (1 listed)
- Children who have no other co existent hematological disorder .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| seum zinic,vit B12, parathyriod functionseum zinic,vit B12, parathyriod function | Diagnostic test | responsiveness to erythropoietin stimulating agent |
Primary outcome
Hb g/dl
Time frame: one year
measure hemoglobin level
Iron profile
Time frame: one year
measure iron profile on blood
Serum creatinine
Time frame: one year
serum creatinine
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Background: PubMed 29023171Allali 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.
- Background: PubMed 29191165Mikhail 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.
- Background: PubMed 21697809Bamgbola 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.
- Background: PubMed 25511161Akbari 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alzahraa A Ahmed, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Patients on Hemodialysis, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hanan N fawzi, specialist (01009351849, hanan_nagdy_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hb g/dl (time frame: one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05312346, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.