Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-25 @ 9:10 PM
Study NCT ID:
NCT06983756
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-21
First Post:
2025-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
" 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 "
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004921', 'term': 'Erythropoietin'}], 'ancestors': [{'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-14', 'studyFirstSubmitDate': '2025-05-14', 'studyFirstSubmitQcDate': '2025-05-14', 'lastUpdatePostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HB', 'timeFrame': '6 month', 'description': 'Hemoglobin in blood'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Erythropoietin Resistant Anemia (EPO Resistant Anemia)']}, 'referencesModule': {'references': [{'pmid': '32144399', 'type': 'BACKGROUND', 'citation': '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': '25080399', 'type': 'BACKGROUND', 'citation': 'Eriguchi 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.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': "Chronic kidney disease (CKD) is a common condition that has significant implications for patients' health and healthcare budgets. CKD is a major contributor to morbidity and mortality across the globe. The incidence and prevalence of CKD are rising steadily all over the world. Along with many adverse effects on different body organs, CKD and end-stage kidney disease (ESKD) are associated with body will beting and malnutrition. Patients with ESKD require maintenance hemodialysis (MHD) to sustain their life.\n\nPatients with chronic kidney disease (CKD) have a relatively deficient erythropoietin (EPO) production, and this is the main cause of anemia in this group. In its severe form, anemia decreases quality of life and increases the risk of cardiovascular diseases and mortality in dialysis patients, so the implementation of prevention and control measures is recommended \\[4\\]. Erythropoiesis-stimulating agents (ESAs) are generally used to control anemia and reduce the need for blood transfusions in patients with CKD.\n\nESA resistance or hyporesponsiveness occurs when the patient does not reach the desired serum hemoglobin (Hb) concentration even with the use of ESA at doses higher than usual or when increasingly higher doses are necessary to maintain the recommended Hb concentration.\n\nThe main causes of EPO resistance are iron deficiency, chronic inflammation, inadequate dialysis, hyperparathyroidism, hemolysis, vitamin B12, and folate deficiency. Observational studies have shown that nutritional status is associated with EPO resistance in HD patients, mainly because of malnutrition-inflammation status.\n\nWhile treating anemic patients with αEPO can increase hemoglobin levels to recommended values and decrease complications in hemodialysis patients, the treatment of anemia with an ESA can increase the risk of mortality; high dosages of the ESA and treatment resistance are the primary factors for this outcome. Thus, it is important to determine which factors limit the ability of αEPO to correct anemia in hemodialysis patients so that treatment can be optimized."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients (and replacements) will be randomly selected by a raffle.\n* All participants should be 18 years of age or older and agree to participate in the study after due clarification.\n* Patients with end stage kidney disease (ESKD) on regular hemodialysis for more than 3 months.\n\nExclusion Criteria:\n\n* \\- Patients with neoplasm, severe cardiovascular, cerebrovascular and liver diseases.\n* Females with polycystic ovarian syndrome, those on hormonal replacement therapy and pregnant women.\n* Patients with infection or autoimmune diseases.'}, 'identificationModule': {'nctId': 'NCT06983756', 'briefTitle': '" 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 "', 'organization': {'class': 'OTHER', 'fullName': 'Fayoum University'}, 'officialTitle': '" 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 "', 'orgStudyIdInfo': {'id': 'Erythropoietin Resistance & MS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'group 1', 'description': 'participants with metabolic syndrome', 'interventionNames': ['Drug: Erythropoietin']}, {'label': 'group 2', 'description': 'participants without metabolic syndrome', 'interventionNames': ['Drug: Erythropoietin']}], 'interventions': [{'name': 'Erythropoietin', 'type': 'DRUG', 'description': 'EPO resistance', 'armGroupLabels': ['group 1', 'group 2']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Nada Elsayed, Bachelor', 'role': 'CONTACT', 'email': 'ne1189@fayoum.edu.eg', 'phone': '01000766880'}, {'name': 'Dr. Marwa Tolba, Assistant Professor', 'role': 'CONTACT', 'email': 'Mka05@fayoum.edu.eg', 'phone': '01067789982'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fayoum University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Teaching Assistant', 'investigatorFullName': 'Nada Elsayed Abdeltwab Issa', 'investigatorAffiliation': 'Fayoum University'}}}}