Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-29 @ 9:30 AM
Study NCT ID:
NCT00746057
Status:
TERMINATED
Last Update Posted:
2013-09-30
First Post:
2008-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of an Early Screening Test of Chronic Rejection and of Operational Tolerance by MicroArray in Renal Graft (Protocol DPRC Array)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020411', 'term': 'Oligonucleotide Array Sequence Analysis'}], 'ancestors': [{'id': 'D009693', 'term': 'Nucleic Acid Hybridization'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017421', 'term': 'Sequence Analysis'}, {'id': 'D046228', 'term': 'Microarray Analysis'}, {'id': 'D046208', 'term': 'Microchip Analytical Procedures'}, {'id': 'D015336', 'term': 'Molecular Probe Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 134}}, 'statusModule': {'whyStopped': 'The number of included patients is sufficient.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-27', 'studyFirstSubmitDate': '2008-09-02', 'studyFirstSubmitQcDate': '2008-09-02', 'lastUpdatePostDateStruct': {'date': '2013-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Transcriptional profile (exhaustive DNAchip) on the blood at 3 months post transplantation.', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Correlation of the transcriptional profile at 3 months after transplantation with histological features of the kidney graft at one year of follow-up.', 'timeFrame': 'One year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Renal graft', 'chronic rejection', 'tolerance', 'DNA chip', 'biopsy'], 'conditions': ['First Cadaveric Renal Graft']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to explore the possibility to identify, at an early stage after a renal graft and from blood samples collected within first months after graft, a predictive transcriptional profile of long term occurence of graft operational tolerance or chronic rejection.\n\nThe aim of the study is to determine an early transcriptional profile of chronic rejection in the transcriptome of mononuclear blood cells. Validation and predictivity of transcriptional analysis will be based on graft function and graft histology one year after transplantation.The other aim is to determine an early transcriptional profile of operational tolerance in the same patients using a DNA chip dedicated including two lists of genes discriminating tolerant patients who are stopped immunosuppressant treatment for over a year.\n\nTo allow statistical analysis of 100 patients followed one year after graft, patients not assessable at one year due to early termination of study will be replaced.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients aged 18 to 65 years old,\n* Donor's age ≤ 60 years old,\n* Patients receiving a first cadaveric renal graft,\n* Patients taking immunosuppressant treatment including an induction with Simulect at day 0 and day 4, FK 506 (Prograf®) associated with Cellcept and steroids (for three months),\n* Patients don't taking indispensable anticoagulant treatment.\n\nExclusion Criteria:\n\n* Patient's age \\< 18 or \\> 65 years old,\n* Donor's age ≥ 60 years old,\n* Pregnant women or breast feeding women,\n* Patients receiving a retransplantation, a kidney and pancreas graft or a graft from a living donor,\n* Patients taking immunosuppressant treatment without FK 506 (Prograf®), Cellcept and steroids.\n* Patients with coagulation troubles or taking indispensable anticoagulant treatment,\n* No biopsy before graft."}, 'identificationModule': {'nctId': 'NCT00746057', 'briefTitle': 'Evaluation of an Early Screening Test of Chronic Rejection and of Operational Tolerance by MicroArray in Renal Graft (Protocol DPRC Array)', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Evaluation of an Early Screening Test of Chronic Rejection and of Operational Tolerance by MicroArray in Renal Graft.', 'orgStudyIdInfo': {'id': '06/2-E'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': 'Patients aged 18 to 65 years old receiving a first cadaveric renal graft.', 'interventionNames': ['Biological: DNA chip']}], 'interventions': [{'name': 'DNA chip', 'type': 'BIOLOGICAL', 'description': 'One biopsy is realized before graft, another biopsy is realized one year after graft and a blood sample is collected 3 months after graft to realize DNA chip. Blood samples are also collected at day 0, day 1, month 3, month 6 and month 12 to analyze biochemistry, proteinuria, haematology, creatinine clearance and immunology at day 0, month 3 and month 12.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nantes', 'country': 'France', 'facility': 'CHU de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}], 'overallOfficials': [{'name': 'Jean-Paul SOULILLOU, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nantes University Hospital'}, {'name': 'Magali GIRAL, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Nantes University Hospital'}, {'name': 'Maryvonne HOURMANT, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Nantes University Hospital'}, {'name': 'Diego CANTAROVICH, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Nantes University Hospital'}, {'name': 'Jacques DANTAL, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Nantes University Hospital'}, {'name': 'Gilles BLANCHO, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Nantes University Hospital'}, {'name': 'Aurélie MEURETTE, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Nantes University Hospital'}, {'name': 'Marie LINO, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Nantes University Hospital'}, {'name': 'Georges MOURAD, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital, Montpellier'}, {'name': 'Lionel ROSTAING, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital, Toulouse'}, {'name': 'Dominique DURAND, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital, Toulouse'}, {'name': 'Christophe LEGENDRE, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'AP-HP (Hôpital Necker)'}, {'name': 'Michèle KESSLER, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'CHU NANCY'}, {'name': 'Emmanuel MORELON, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospices Civils de Lyon'}, {'name': 'Sameh DAOUD, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospices Civils de Lyon'}, {'name': 'Cécile CHAUVET, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospices Civils de Lyon'}, {'name': 'Olivier THAUNAT, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospices Civils de Lyon'}, {'name': 'Jean-François SUBRA, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital, Angers'}, {'name': 'François BAYLE, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital, Grenoble'}, {'name': 'Elisabeth CASSUTO, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'CHU NICE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}}}}