Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-01-03 @ 11:55 AM
Study NCT ID:
NCT00684034
Status:
COMPLETED
Last Update Posted:
2014-08-28
First Post:
2008-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Redox State in the Course of Chronic Renal Insufficiency and Hemodialysis: Implications in Morbimortality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 131}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-27', 'studyFirstSubmitDate': '2008-05-21', 'studyFirstSubmitQcDate': '2008-05-23', 'lastUpdatePostDateStruct': {'date': '2014-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'This study should allow to clarify the redox state some plasma by quantification of thiols membranous on the surface of lymphocytes at the hemodialysis and insufficient renal chronic not dialysed patients.', 'timeFrame': '48 months'}], 'secondaryOutcomes': [{'measure': 'This study should allow to estimate in a forward-looking longitudinal plan the possible involvement of the parameters of the redox state and the morbidity and the cardiovascular and global mortality in 2 years in 2 studied populations.', 'timeFrame': '48 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Redox state in the course of chronic renal insufficiency and hemodialysis.'], 'conditions': ['Chronic Renal Insufficiency']}, 'descriptionModule': {'briefSummary': 'The influence of hemodialysis on oxidative stress, endothelial activation, inflammation and on the redox state of lymphocytes should be clarified as well as the putative relationships between all these parameters.', 'detailedDescription': 'Up to now, no anti-oxydative treatment has been able to reduce the mortality of the patients with Kidney Failure. Thus it is necessary to have a better knowledge of oxydative stress mechanisms in patients with KF in order to find more efficacious treatments. The influence of hemodialysis upon oxidative stress is not well known.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 and 80 years old man or woman dialysing at least 3 times a week for at least 6 months and having no residual renal function\n* Rate of haemoglobin \\> 11 g / dl\n* Clinically stable patient that is having had no considerable event (cardiovascular problem, infection, surgical operation) with the exception of angioplasty of fistula or prosthesis vascular, in the previous 3 months the entrance to the study\n* Patient capable of understanding and of following the essay, in particular knowing how to read the note of information.\n\nExclusion Criteria:\n\n* Pregnant woman\n* Treatment by corticoids or immunosuppresseurs\n* hemopathy sly\n* chronic cancer or infection in evolution\n* Cardiovascular event (infarct, unstable angor, coronary bypasses, confusions of the rhythm, AVC, amputation) or infectious (blood-poisoning, pneumopathie, meningitis) or surgical operation in the previous 3 months the inclusion in the study.'}, 'identificationModule': {'nctId': 'NCT00684034', 'briefTitle': 'Redox State in the Course of Chronic Renal Insufficiency and Hemodialysis: Implications in Morbimortality', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'Redox State in the Course of Chronic Renal Insufficiency and Hemodialysis: Implications in Morbimortality', 'orgStudyIdInfo': {'id': '2007-A01179-44'}, 'secondaryIdInfos': [{'id': '2007-38'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': 'Volunteer healthy', 'interventionNames': ['Other: Sampling of blood']}, {'type': 'OTHER', 'label': '2', 'description': 'Patient dialysis patient', 'interventionNames': ['Other: Sampling of blood']}, {'type': 'OTHER', 'label': '3', 'description': 'Not dialysed chronic renal insufficient patient', 'interventionNames': ['Other: Sampling of blood']}], 'interventions': [{'name': 'Sampling of blood', 'type': 'OTHER', 'description': 'A sampling of blood will be made', 'armGroupLabels': ['1']}, {'name': 'Sampling of blood', 'type': 'OTHER', 'description': 'A sampling of bood will be made before the dialysis', 'armGroupLabels': ['2']}, {'name': 'Sampling of blood', 'type': 'OTHER', 'description': 'A sampling of blood will be made.', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13385', 'city': 'Marseille', 'country': 'France', 'facility': 'Hopital de la Conception- Service de Néphrologie et de transplantation rénale', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'overallOfficials': [{'name': 'Bertrand DUSSOL, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique des Hopitaux de Marseille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}