Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2026-01-04 @ 4:37 PM
Study NCT ID:
NCT00492895
Status:
COMPLETED
Last Update Posted:
2013-01-29
First Post:
2007-06-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Photosensitivity of the Skin Under Azathioprin in Renal Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012878', 'term': 'Skin Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-28', 'studyFirstSubmitDate': '2007-06-19', 'studyFirstSubmitQcDate': '2007-06-26', 'lastUpdatePostDateStruct': {'date': '2013-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Photosensitivity of the skin to UVA and UVB', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Skin Cancer']}, 'referencesModule': {'references': [{'pmid': '21943390', 'type': 'RESULT', 'citation': 'Hofbauer GF, Attard NR, Harwood CA, McGregor JM, Dziunycz P, Iotzova-Weiss G, Straub G, Meyer R, Kamenisch Y, Berneburg M, French LE, Wuthrich RP, Karran P, Serra AL. Reversal of UVA skin photosensitivity and DNA damage in kidney transplant recipients by replacing azathioprine. Am J Transplant. 2012 Jan;12(1):218-25. doi: 10.1111/j.1600-6143.2011.03751.x. Epub 2011 Sep 22.'}]}, 'descriptionModule': {'briefSummary': 'Photosensitivity of the skin to UVA and UVB will be determined', 'detailedDescription': 'Photosensitivity of the skin to UVA and UVB in renal transplant recipients with and without azathioprine will be determined. Azathioprine will be discontinued and photosensitivity determined after a wash-out period of three months\n\n* Trial with medicinal product'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Renal transplant recipients under azathioprin\n\nExclusion criteria:\n\n* Treatment with Prograf (Tacrolimus)'}, 'identificationModule': {'nctId': 'NCT00492895', 'briefTitle': 'Photosensitivity of the Skin Under Azathioprin in Renal Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Photosensitivity of the Skin Under Azathioprin in Renal Transplant Recipients', 'orgStudyIdInfo': {'id': '2007DR2040'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'A', 'description': 'one arm only. Crossover study', 'interventionNames': ['Drug: Discontinuation of Azathioprin']}], 'interventions': [{'name': 'Discontinuation of Azathioprin', 'type': 'DRUG', 'description': 'Discontinuation of Azathioprin', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Clinic for Dermatology, University Hospital of Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Günther Hofbauer, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UniversitaetsSpital Zuerich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}