Erythropoietin Resistant Anemia (EPO Resistant Anemia)NCT06053866
Prevalence of Erythropoiesis Stimulating Agents Hyporesponsiveness in Dialysis Patients in Assiut University Hospital
An observational study of Erythropoietin Resistant Anemia (EPO Resistant Anemia), run by Assiut University.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Erythropoietin Resistant Anemia (EPO Resistant Anemia)
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 1 Mar 2025
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: End stage renal disease patients undergoing regular hemodialysis for at least 3 months duration
Who may be able to join
- age more than 18
- End stage renal disease patients undergoing regular hemodialysis in Assiut University Hospital - Hemodialysis unit for duration at least 3 months
Who cannot join
- acute infectious disease within one month
- active liver disease or cancer
- recent blood transfusion or surgical intervention
- active bleeding or hemorrhage
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prevalence of Erthropoietin Stimulating Agents Hyporesponsiveness and Its Correlation With Cardiovascular Morbidities in Hemodialysis Patients in Assiut University Hospital
- 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
Read the detailed description
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One year
Secondary outcomes (1)
Assessment of cardiovascular diseases risk in hemodialysis patients with erythropoiesis stimulating agents hyporesponsiveness
Echocardiography
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 posted26 Sep 2023
- Study start1 Feb 2024 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Erythropoietin Resistant Anemia (EPO Resistant Anemia)Studies of the same condition, open and under way.
- More trials run by Assiut 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
- Other
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feby Rasmy Khalifa Makar, Assiut University
- Investigators
- Hewida Abdelhakem Nafady, Principal investigator, Assiut UniversityRadwa Awad abdelhafez, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06053866
- Sponsor's protocol ID
- Erythropoietin resistance
- Status last verified
- Jan 2024
- First submitted
- 13 Sep 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 20640598Bamgbola 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.
PubMed 18800231Del 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.
PubMed 15648023Tanaka 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.
PubMed 35507237Okazaki 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.
PubMed 24603656Lopez-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.
PubMed 19034333Lu 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.
PubMed 33293895Chung 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.
PubMed 22103889
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Erthropoietin Stimulating Agents Hyporesponsiveness and Its Correlation With Cardiovascular Morbidities in Hemodialysis Patients in Assiut University Hospital
- ClinicalTrials.gov ID
- NCT06053866
- Acronym / sponsor ID
- Erythropoietin resistance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 26 Sep 2023 (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.
- 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
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- End stage renal disease patients undergoing regular hemodialysis for at least 3 months duration
Key inclusion criteria (2 listed)
- age more than 18
- End stage renal disease patients undergoing regular hemodialysis in Assiut University Hospital - Hemodialysis unit for duration at least 3 months
Key exclusion criteria (4 listed)
- acute infectious disease within one month
- active liver disease or cancer
- recent blood transfusion or surgical intervention
- active bleeding or hemorrhage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of the prevalence of Erythropoiesis stimulating agents hyporesponsiveness in dialysis patients in Assiut university hospital
Time frame: One year
Erythropoiesis resistance index which is the erythropoietin dose per week divided by body weight and Hemoglobin level
1 secondary outcome
Assessment of cardiovascular diseases risk in hemodialysis patients with erythropoiesis stimulating agents hyporesponsiveness
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Background: PubMed 20640598de 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.
- Background: PubMed 18800231Bamgbola 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.
- Background: PubMed 15648023Del 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.
- Background: PubMed 35507237Tanaka 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.
- Background: PubMed 24603656Okazaki 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.
- Background: PubMed 19034333Lopez-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.
- Background: PubMed 33293895Lu 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.
- Background: PubMed 22103889Chung 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.
- Individual participant dataSharing planned: Undecided
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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.
Hewida Abdelhakem Nafady principal investigator
Assiut University
Radwa Awad abdelhafez study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Erythropoietin Resistant Anemia (EPO Resistant Anemia), run by Assiut University.
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 2 inclusion and 4 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 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Feby Rasmy Khalifa (+201015508087, fybyrsmy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the prevalence of Erythropoiesis stimulating agents hyporesponsiveness in dialysis patients in Assiut university hospital (time frame: One year). 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 NCT06053866, which also lists 8 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 31 Jan 2024.