Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-26 @ 8:38 PM
Study NCT ID:
NCT01017757
Status:
UNKNOWN
Last Update Posted:
2009-11-23
First Post:
2009-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interstitial Lung Abnormalities in Renal Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2009-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-11-20', 'studyFirstSubmitDate': '2009-11-18', 'studyFirstSubmitQcDate': '2009-11-20', 'lastUpdatePostDateStruct': {'date': '2009-11-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subclinical lung alterations as assessed by high-resolution CT scanning', 'timeFrame': 'CT is performed at study entry and, if abnormalities are found, it is repeated at 3-6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Interstitial lung disease', 'Immunosuppressive therapy', 'Renal transplant'], 'conditions': ['Renal Transplantation', 'Kidney-pancreas Transplantation']}, 'descriptionModule': {'briefSummary': 'Immunosuppressive drugs such as tacrolimus, cyclosporine, mycophenolate mofetil, sirolimus and everolimus may have toxic pulmonary effects, particularly interstitial alterations. The aim of the present study is to explore the presence of subclinical interstitial lung abnormalities in stable renal transplant recipients taking the different immunosuppressive drugs used as maintenance therapy for renal transplantation.', 'detailedDescription': 'Prospective, cross-sectional study examining the high-resolution CT scans obtained in 63 stable renal transplant recipients taking immunosuppressive treatment for at least 24 months. The findings in patients taking the newer immunosuppressive drugs (mycophenolic acid, sirolimus and everolimus) are compared with those of the patients treated in the traditional way (cyclosporine, tacrolimus, azathioprine). All patients undergo high-resolution CT scanning.\n\nEligibility criteria: recipients of kidney or kidney-pancreas transplant, on immunosuppressive therapy for at least 24 months, with stable renal function and absence of any overt lung disease or lung alterations induced by other drugs, systemic diseases or occupational exposure to fibrogenic agents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '82 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Kidney or kidney-pancreas recipients, on immunosuppressive therapy for at least 24 months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Renal transplant patients with stable renal function taking immunosuppressive therapy for at least 24 months and providing written informed consent to participate to the study\n\nExclusion Criteria:\n\n* Overt lung disorders, lung toxicity due to other drugs or occupational exposure to lung-toxic agents\n* Systemic connective tissue disorders or systemic vasculitis'}, 'identificationModule': {'nctId': 'NCT01017757', 'acronym': 'LCRT', 'briefTitle': 'Interstitial Lung Abnormalities in Renal Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': 'University of Parma'}, 'officialTitle': 'Cross-sectional Analysis of Subclinical Interstitial Lung Abnormalities in Stable Renal Transplant Recipients by High-resolution CT Scan', 'orgStudyIdInfo': {'id': 'LungCtRenalTx'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Renal transplant patients', 'interventionNames': ['Procedure: High-resolution CT scanning']}], 'interventions': [{'name': 'High-resolution CT scanning', 'type': 'PROCEDURE', 'description': 'High-resolution CT scanning', 'armGroupLabels': ['Renal transplant patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43100', 'city': 'Parma', 'state': 'Parma', 'country': 'Italy', 'facility': 'Department of Clinical Medicine Nephrology and Health Science, Parma University Hospital', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}], 'overallOfficials': [{'name': 'Carlo Buzio, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Parma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Parma', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Carlo Buzio', 'oldOrganization': 'University of Parma'}}}}