Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
Study NCT ID:
NCT05586867
Status:
RECRUITING
Last Update Posted:
2022-10-19
First Post:
2022-10-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Markers of Iron Metabolism and Their Relationship With Phosphocalcic and Hepatic Metabolism and Inflammation in Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019189', 'term': 'Iron Metabolism Disorders'}], 'ancestors': [{'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006403', 'term': 'Hematologic Tests'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2031-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-17', 'studyFirstSubmitDate': '2022-10-17', 'studyFirstSubmitQcDate': '2022-10-17', 'lastUpdatePostDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'concentration of the two main markers concerning iron metabolism: hepcidin (ng/ml) and erythroferone (ng/ml).', 'timeFrame': '5 years', 'description': 'These will be dosed twice over a year of dialysis and for 5 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Iron Metabolism Disorders', 'Calcium Phosphate Metabolism', 'Hepatic Metabolic Disorders', 'Hemodialysis Complication']}, 'descriptionModule': {'briefSummary': 'From a scientific point of view and for publication purposes, it therefore seems important to study the metabolism of iron and in particular to define its conditions of absorption, metabolism, elimination and storage in the body at course of advanced renal failure.\n\nThe study will follow the evolution of hormones regulating iron metabolism and put into perspective their links with phosphocalcic and hepatic metabolisms as well as inflammation in hemodialysis patients.\n\nThe main objective of this program is to study the evolution of hepcidin and erythroferrone levels in hemodialysis patients. These two biomarkers regulating iron metabolism are not performed routinely in dialysis centers and are not listed in the nomenclature.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hemodialysis adult patient', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult dialysis patient\n* Patient able to understand the information necessary for the study and having signed his written consent to participate\n* Affiliated patient or beneficiary of a social security scheme.\n\nExclusion Criteria:\n\n* Medically unstable or frail patient\n* Patient with hemoglobin less than 7g/dl\n* Patient with HIV+ or AIDS, patient with replicating hepatitis B or C\n* Patient participating in another clinical study requiring an additional blood sample\n* Patient benefiting from legal protection measures (guardianship, guardianship, etc.) adult under guardianship, guardianship or other legal protection, deprived of freedom by judicial or administrative decision\n* Pregnant, breastfeeding or parturient woman'}, 'identificationModule': {'nctId': 'NCT05586867', 'acronym': 'MARMEFE', 'briefTitle': 'Study of Markers of Iron Metabolism and Their Relationship With Phosphocalcic and Hepatic Metabolism and Inflammation in Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ramsay Générale de Santé'}, 'officialTitle': 'Study of Markers of Iron Metabolism and Their Relationship With Phosphocalcic and Hepatic Metabolism and Inflammation in Hemodialysis Patients', 'orgStudyIdInfo': {'id': '2021-A01329-32'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hemodialysis patient', 'interventionNames': ['Procedure: Blood test']}], 'interventions': [{'name': 'Blood test', 'type': 'PROCEDURE', 'description': '15 mL of blood to follow the evolution of hepcidin and erythroferrone levels', 'armGroupLabels': ['Hemodialysis patient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91480', 'city': 'Quincy-sous-Sénart', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Guy ROSTOKER, Dr', 'role': 'CONTACT', 'email': 'rostotom@orange.fr', 'phone': '06 03 00 42 91'}], 'facility': 'Hôpital Privé Claude Galien', 'geoPoint': {'lat': 48.67294, 'lon': 2.53419}}], 'centralContacts': [{'name': 'Jean-François Oudet', 'role': 'CONTACT', 'email': 'jeanfrancois.oudet@free.fr', 'phone': '0683346567'}, {'name': 'Marie-Hélène Barba', 'role': 'CONTACT', 'email': 'mh.barba@ecten.eu'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ramsay Générale de Santé', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Clinical Trial Experts Network', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}