Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:45 AM
Study NCT ID:
NCT00395902
Status:
COMPLETED
Last Update Posted:
2007-12-28
First Post:
2006-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post Transplant Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006962', 'term': 'Hyperparathyroidism, Secondary'}, {'id': 'D006961', 'term': 'Hyperparathyroidism'}], 'ancestors': [{'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'lastUpdateSubmitDate': '2007-12-20', 'studyFirstSubmitDate': '2006-11-02', 'studyFirstSubmitQcDate': '2006-11-02', 'lastUpdatePostDateStruct': {'date': '2007-12-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-06', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Sensipar', 'cinacalcet', 'Mimpara'], 'conditions': ['Kidney Tansplant', 'Secondary Hyperparathyroidism', 'Hyperparathyroidism']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'Retrospective chart review to gather information on Sensipar patterns of use and effects on biochemical parameters in renal transplant recipients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults \\>= 18 years old\n* Subjects who have received Sensipar for a duration of at least 3 months, beginning at least 3 months after a kidney transplant. Subjects must have begun Sensipar teatment no later than Februry 28, 2005 at treating physician's discretion.\n\nExclusion Criteria:\n\n* Subjects who received Sensipar before undergoing a kidney transplant\n* Subjects receiving dialysis post-transplant"}, 'identificationModule': {'nctId': 'NCT00395902', 'briefTitle': 'Post Transplant Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Retrospective Evaluation of Sensipar Use in Renal Transplant Recipients', 'orgStudyIdInfo': {'id': '20040261'}, 'secondaryIdInfos': [{'id': '2004261'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Sensipar after Post Transplant', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Global Development Leader', 'oldOrganization': 'Amgen Inc.'}}}}