Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2025-12-24 @ 11:50 AM
Study NCT ID:
NCT03503461
Status:
COMPLETED
Last Update Posted:
2018-11-14
First Post:
2018-04-11
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Major Activation Of NCC in Graft Urinary Exosomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D000138', 'term': 'Acidosis'}, {'id': 'C537288', 'term': 'Gordon syndrome'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000137', 'term': 'Acid-Base Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-12', 'studyFirstSubmitDate': '2018-04-11', 'studyFirstSubmitQcDate': '2018-04-18', 'lastUpdatePostDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NCC cotransporter expression', 'timeFrame': 'Inclusion day', 'description': 'Dosage of NCC cotransporter expression in urinary exosomes samples in both groups.'}], 'secondaryOutcomes': [{'measure': 'Phosphorylated NCC cotransporter expression', 'timeFrame': 'Inclusion day', 'description': 'Dosage of phosphorylated NCC cotransporter expression in urinary exosomes samples in both groups.'}, {'measure': 'pendrine expression in kidney transplant group', 'timeFrame': 'Inclusion day', 'description': 'Dosage of pendrine expression in urinary exosomes samples in kidney transplant group.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Calcineurin inhibitors', 'hypertension', 'kidney transplant', 'acidosis', 'Gordon syndrome'], 'conditions': ['Kidney Transplantation']}, 'descriptionModule': {'briefSummary': 'Hypertension is common disorder after renal transplantation and is associated with mortality. Calcineurin Inhibitor (CNI), by activating NCC cotransporter, may be a major determinant of hypertension, included in a "Gordon like" syndrome. However, prevalence of NCC activation by CNI is unknown. Our objective is to determine the prevalence of NCC activation three months after transplantation in patient treated by CNI.', 'detailedDescription': 'Hypertension is common disorder after renal transplantation and is associated with mortality. Calcineurin Inhibitor (CNI), by activating NCC cotransporter, may be a major determinant of hypertension, included in a "Gordon like" syndrome. Gordon syndrome is a rare genetic disorder where NCC cotransporter is overactivated and cause hypertension, metabolic acidosis and tendency to hyperkaliemia. Few studies evaluated NCC expression by exosomes techniques in human kidney transplant, and mostly compared NCC expression in specific subpopulation (for example with or without hypertension). Thus, prevalence of NCC activation by CNI is unknown. To determine it, we will include prospective patients in Bordeaux and la Réunion who undergo urine and blood tests three months after transplantation, and a control group with no transplantation and no use of CNI. First, we will compare kidney recipients and control and use immunoblot to quantify NCC expression in urinary exosomes to identify the population of transplanted with a high activation. Then, we will analyze the relationship between NCC activation and clinicobiological features of Gordon\'s syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Kidney transplant group is a population of transplant subjects treated with anticalcineurin since 3 months.\n\nControl group is a population of subjects admitted to day hospitalization for renal function tests or in conventional hospitalization, but without kidney transplant.', 'healthyVolunteers': True, 'eligibilityCriteria': 'For kidney transplant group :\n\n* inclusion criteria:\n\n * Age≥18years\n * Recipients three months after kidney transplantation using calcineurin inhibitors\n * Glomerular Filtration Rate\\>15ml.mn.m2 CKD-EPI\n * Renal ultrasound underwent before inclusion\n * No opposition at participating at the research\n* exclusion criteria:\n\n * Use of diuretic thiazides or aldosterone receptor antagonists in the month preceding inclusion\n * Graft artery stenosis with indication of interventional radiology or surgery\n\nFor control group :\n\n* Inclusion criteria\n\n * No previous transplantation\n * Age≥18years\n * No hypertension\n * No metabolic disorders (dysnatremia, dyskaliemia, acidosis or alkalosis)\n * No opposition at participating at the research\n* Exclusion criteria:\n\n * Use of diuretic thiazides or aldosterone receptor antagonists in the month preceding inclusion'}, 'identificationModule': {'nctId': 'NCT03503461', 'acronym': 'MANGUE', 'briefTitle': 'Major Activation Of NCC in Graft Urinary Exosomes', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'Evaluation of the Prevalence of an Hyperactivation of NCC Cotransporter Three Months After Kidney Transplantation in Recipients Treated by Calcineurin Inhibitors', 'orgStudyIdInfo': {'id': 'CHUBX 2018/08'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control group', 'description': 'Control group is a population of subjects admitted to day hospitalization for renal function tests or in conventional hospitalization, but without kidney transplant. Exosome analysis will be perform in urine sample.', 'interventionNames': ['Other: exosomes analysis']}, {'label': 'Kidney transplants group', 'description': 'Kidney transplants group is a kidney transplant subjects population 3 months ago. Exosome analysis will be perform in urine sample collected at 3 months.', 'interventionNames': ['Other: exosomes analysis']}], 'interventions': [{'name': 'exosomes analysis', 'type': 'OTHER', 'description': 'Perform exosomes analysis in urine sample obtain from usual urine testing in both kidney transplant and control group.', 'armGroupLabels': ['Control group', 'Kidney transplants group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33000', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Hopital Pellegrin - Service Néphrologie, transplantation, dialyse et aphérèse', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '97400', 'city': 'Saint-Denis', 'country': 'Reunion', 'facility': "Hopital Felix Guyon - Service d'Explorations Fonctionnelles Rénales", 'geoPoint': {'lat': -20.88231, 'lon': 55.4504}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}