Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT00687518
Status:
UNKNOWN
Last Update Posted:
2008-05-30
First Post:
2008-05-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Intravenous Injection of Erythropoietin on Hepcidin Pharmacokinetics in Healthy Volunteers
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': 'D004921', 'term': 'Erythropoietin'}, {'id': 'C103998', 'term': 'epoetin beta'}], '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 14}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2009-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-05-29', 'studyFirstSubmitDate': '2008-05-27', 'studyFirstSubmitQcDate': '2008-05-29', 'lastUpdatePostDateStruct': {'date': '2008-05-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serum hepcidin levels', 'timeFrame': 'over 24 hours'}], 'secondaryOutcomes': [{'measure': 'urinary hepcidin levels', 'timeFrame': 'over 24 hours'}, {'measure': 'serum iron and ferritin levels', 'timeFrame': 'over 24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Iron Metabolism Disorders']}, 'referencesModule': {'references': [{'pmid': '21818622', 'type': 'DERIVED', 'citation': 'Laine F, Laviolle B, Ropert M, Bouguen G, Morcet J, Hamon C, Massart C, Westermann M, Deugnier Y, Loreal O. Early effects of erythropoietin on serum hepcidin and serum iron bioavailability in healthy volunteers. Eur J Appl Physiol. 2012 Apr;112(4):1391-7. doi: 10.1007/s00421-011-2097-7. Epub 2011 Aug 5.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to measure the variations of serum and urinary hepcidin levels following a single intravenous injection of erythropoietin in healthy volunteers. Hepcidin is a major regulator of iron homeostasis. It acts by binding on ferroportin, and limits cellular efflux of iron through enterocytes and macrophages. Anemia and hypoxia are known to modulate hepcidin synthesis. In these situations, erythropoietin synthesis is increased, so it can be postulated that erythropoietin could modulate hepcidin synthesis.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy volunteers\n* male aged 18 - 30\n* normal routine laboratory values\n* normal ECG\n* normal iron status\n\nExclusion Criteria:\n\n* C282Y mutation of the HFE gene\n* alcohol or tobacco consumption'}, 'identificationModule': {'nctId': 'NCT00687518', 'acronym': 'HEPEPO', 'briefTitle': 'Effects of Intravenous Injection of Erythropoietin on Hepcidin Pharmacokinetics in Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': 'Effects of Intravenous Injection of Erythropoietin on Hepcidin Pharmacokinetics in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'DGS 2006/0416'}, 'secondaryIdInfos': [{'id': 'CIC0203/056'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'erythropoietin', 'interventionNames': ['Drug: Erythropoietin']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Saline serum', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Erythropoietin', 'type': 'DRUG', 'otherNames': ['Neorecormon®'], 'description': 'Intravenous injection of 50 U/kg of erythropoietin', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['NaCl 0,9%'], 'description': 'Intravenous injection of equivalent volume of saline serum', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35033', 'city': 'Rennes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Fabrice LAINE, MD', 'role': 'CONTACT', 'email': 'fabrice.laine@chu-rennes.fr', 'phone': '33-2-9928-9199'}, {'name': 'Fabrice LAINE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Unité d'Investigation Clinique - Centre d'Investigation Clinique - Hôpital de Pontchaillou", 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}], 'centralContacts': [{'name': 'Fabrice LAINE, MD', 'role': 'CONTACT', 'email': 'fabrice.laine@chu-rennes.fr', 'phone': '33-2-9928-9199'}], 'overallOfficials': [{'name': 'Fabrice LAINE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rennes University Hospital'}, {'name': 'Bruno LAVIOLLE, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'RennesUniversity Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Direction of Clinical Research and Strategy', 'oldOrganization': 'Rennes University Hospital'}}}}