Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-01-03 @ 10:19 PM
Study NCT ID:
NCT02159651
Status:
COMPLETED
Last Update Posted:
2024-10-22
First Post:
2014-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Survey for Long-term Use of Prograf Capsules in Patient With Interstitial Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003882', 'term': 'Dermatomyositis'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}], 'ancestors': [{'id': 'D017285', 'term': 'Polymyositis'}, {'id': 'D009220', 'term': 'Myositis'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016559', 'term': 'Tacrolimus'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 179}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-19', 'studyFirstSubmitDate': '2014-06-06', 'studyFirstSubmitQcDate': '2014-06-06', 'lastUpdatePostDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'Up to three years'}], 'secondaryOutcomes': [{'measure': 'Respiratory function test value (%FVC, %DLco)', 'timeFrame': 'Up to three years', 'description': 'Respiratory function is evaluated by % FVC ( percent-predicted forced vital capacity) amd %DLco (diffusion capacity of CO).'}, {'measure': 'Arterial blood gas analysis value (PaO2, AaDO2)', 'timeFrame': 'Up to three years', 'description': 'Arterial blood gas analysis by PaO2 (arterial O2 pressure) and AaDO2 (alveolar-arterial oxygen difference)'}, {'measure': 'Chest CT findings', 'timeFrame': 'Up to three years', 'description': 'CT: computed tomography'}, {'measure': 'Serum KL-6 value (serum SP-D value)', 'timeFrame': 'Up to three years', 'description': 'KL-6 (sialylated carbohydrate antigen KL-6) and SP-D (surfactant protein D) are used as marker of interstitial pneumonia'}, {'measure': 'Patient disposition', 'timeFrame': 'Up to three years', 'description': 'patient disposition includes 1)number of case report forms collected, 2)number of patients analyzed for safety, 3)number of patients analysed for efficacy'}, {'measure': 'Safety assessed by the incidence of adverse events', 'timeFrame': 'Up to three years', 'description': 'Any adverse events which include adverse events leading to death, white blood cell count, erythrocyte sedimentation rate and other abnormal findings from laboratory tests'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tacrolimus', 'interstitial pneumonia', 'prograf'], 'conditions': ['Interstitial Pneumonia Associated With Polymyositis/Dermatomyositis']}, 'referencesModule': {'references': [{'pmid': '35428708', 'type': 'DERIVED', 'citation': 'Kuwana M, Wakasugi N, Furuya T, Uno S, Suda T. Tacrolimus in Patients With Interstitial Pneumonia Associated With Polymyositis or Dermatomyositis: Interim Report of Postmarketing Surveillance in Japan. J Rheumatol. 2022 Jul;49(7):707-718. doi: 10.3899/jrheum.210322. Epub 2022 Apr 15.'}]}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the safety and the efficacy of Prograf in patients with interstitial pneumonia associated with polymyositis / dermatomyositis in acute clinical setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with interstitial pneumonia associated with polymyositis/dermatomyositis who treated with Prograf', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospitalized patient\n* Patient diagnosed with Interstitial pneumonia associated with polymyositis/dermatomyositis'}, 'identificationModule': {'nctId': 'NCT02159651', 'briefTitle': 'A Survey for Long-term Use of Prograf Capsules in Patient With Interstitial Pneumonia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'Specified Drug Use-results Survey for Long-term Use of Prograf Capsules in Patient With Interstitial Pneumonia Associated With Polymyositis/Dermatomyositis', 'orgStudyIdInfo': {'id': 'PRGI01'}, 'secondaryIdInfos': [{'id': '506-MA-PRGI-01', 'type': 'OTHER', 'domain': 'Japan Medical Affairs'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '1: Dermatomyositis group', 'description': 'patients with interstitial pneumonia associated with dermatomyositis', 'interventionNames': ['Drug: tacrolimus']}, {'label': '2: Polymyositis group', 'description': 'patients with interstitial pneumonia associated with polymyositis', 'interventionNames': ['Drug: tacrolimus']}], 'interventions': [{'name': 'tacrolimus', 'type': 'DRUG', 'otherNames': ['FK506', 'Prograf'], 'description': 'oral', 'armGroupLabels': ['1: Dermatomyositis group', '2: Polymyositis group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chugoku', 'country': 'Japan'}, {'city': 'Chūbu', 'country': 'Japan', 'geoPoint': {'lat': 35.43379, 'lon': 140.2797}}, {'city': 'Hokkaido', 'country': 'Japan'}, {'city': 'Kansai', 'country': 'Japan'}, {'city': 'Kanto', 'country': 'Japan'}, {'city': 'Kyushu', 'country': 'Japan'}, {'city': 'Shikoku', 'country': 'Japan'}, {'city': 'Tōhoku', 'country': 'Japan', 'geoPoint': {'lat': 35.81882, 'lon': 139.57138}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma Inc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}