Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT00044720
Status:
COMPLETED
Last Update Posted:
2009-08-18
First Post:
2002-09-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Evaluating Sirolimus in End Stage Renal Disease in High Risk Kidney Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020123', 'term': 'Sirolimus'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 484}}, 'statusModule': {'overallStatus': 'COMPLETED', 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2005-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-17', 'studyFirstSubmitDate': '2002-09-04', 'studyFirstSubmitQcDate': '2002-09-05', 'lastUpdatePostDateStruct': {'date': '2009-08-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-09-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-07', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Kidney Transplant'], 'conditions': ['Chronic Kidney Failure', 'Graft vs Host Disease', 'Kidney Transplantation']}, 'descriptionModule': {'briefSummary': 'The incidence of efficacy failure at 12 months between two regimens.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Age: 13 years or older, 40 kgs or more\n* End-stage renal disease\n* African-American/Black transplant recipient and/or repeat renal transplant recipient who lost a previous allograft\n\nExclusion Criteria\n\n* Evidence of active infection\n* Evidence abnormal chest x-ray\n* Patients with HIV.'}, 'identificationModule': {'nctId': 'NCT00044720', 'briefTitle': 'Study Evaluating Sirolimus in End Stage Renal Disease in High Risk Kidney Transplant Recipients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'An Open-label, Concentration Controlled, Randomized, 12 Month Study of Prograf + Rapamune + Cor', 'orgStudyIdInfo': {'id': '0468H1-101164'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Rapamune', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wyeth is now a wholly owned subsidiary of Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}}}}