Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-01-25 @ 8:15 AM
Study NCT ID:
NCT02857556
Status:
TERMINATED
Last Update Posted:
2019-05-03
First Post:
2016-08-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Potential Biomarkers of the Severity of Endothelial Damage in End-stage Chronic Kidney Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'Lack of inclusions', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-02', 'studyFirstSubmitDate': '2016-08-02', 'studyFirstSubmitQcDate': '2016-08-02', 'lastUpdatePostDateStruct': {'date': '2019-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Activation of 5 proteins relocated in the membrane of monocytes (eNOS, iNOS, gp91phox and receptors of angiotensin II (AT1 and AT2)) within dynamic lipid structures, rafts, measured by western blot-dot blot.', 'timeFrame': 'at the beginning of the period Day 0, at 1 month and at 3 months.'}]}, 'conditionsModule': {'conditions': ['End-stage Chronic Kidney Failure']}, 'descriptionModule': {'briefSummary': 'The principal objective of this study is to qualify markers of oxidative stress in inflammatory cells (monocytes) in patients with stage 3 kidney failure (diabetic or not), and patients with end-stage kidney failure (diabetic or not), who require dialysis. The evaluation of these markers will be done by the activation and localization of proteins implicated in vascular tone and oxidative stress in monocytes, correlated with the distribution of cholesterol sphingomyelin within planar rafts and caveolae. The aim is to describe their evolution under treatment, which could lead to interventional studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient who have been informed about the research\n* Patients with national health insurance cover\n* Patients aged between 18 and 75 years\n* Patients with stage 3 kidney failure (30 ml/min \\< cl creat \\< 59 ml/min) diabetic or not\n* Patients with stage 5 kidney failure (cl creat \\< 15 ml/mn) diabetic or not and requiring dialysis.\n\nExclusion Criteria:\n\n* Patients under guardianship\n* Pregnant or breast-feeding women\n* Infection (including peritonitis in peritoneal dialysis, infection of the catheter insertion site),\n* Neoplastic disease,\n* Systemic diseases in flare,\n* Patients positive for Human Immunodeficience Virus (HIV),\n* Patients on immunosuppressants\n* Patients taking antioxidants (selenium, vitamin C and/or E)\n* Patient on statins'}, 'identificationModule': {'nctId': 'NCT02857556', 'acronym': 'DIALYSOX', 'briefTitle': 'Potential Biomarkers of the Severity of Endothelial Damage in End-stage Chronic Kidney Failure', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Potential Biomarkers of the Severity of Endothelial Damage in End-stage Chronic Kidney Failure Evaluated at the Initiation of Intermittent or Peritoneal Dialysis', 'orgStudyIdInfo': {'id': 'GAMBERT Fd. Transpl 2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'group with stage 3 kidney failure (diabetic or not)', 'interventionNames': ['Biological: Blood sample', 'Other: Retinal photography:']}, {'type': 'OTHER', 'label': 'group with stage 5 kidney failure (diabetic or not)', 'interventionNames': ['Biological: Blood sample', 'Other: dialyse']}], 'interventions': [{'name': 'Blood sample', 'type': 'BIOLOGICAL', 'armGroupLabels': ['group with stage 3 kidney failure (diabetic or not)', 'group with stage 5 kidney failure (diabetic or not)']}, {'name': 'Retinal photography:', 'type': 'OTHER', 'armGroupLabels': ['group with stage 3 kidney failure (diabetic or not)']}, {'name': 'dialyse', 'type': 'OTHER', 'armGroupLabels': ['group with stage 5 kidney failure (diabetic or not)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'CHU Dijon Bourgogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}