Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT00885820
Status:
COMPLETED
Last Update Posted:
2014-09-18
First Post:
2009-04-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Benefit of Early Protocol Biopsy and Treatment of Subclinical Rejection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016559', 'term': 'Tacrolimus'}, {'id': 'D009173', 'term': 'Mycophenolic Acid'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D008775', 'term': 'Methylprednisolone'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2006-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-17', 'studyFirstSubmitDate': '2009-04-20', 'studyFirstSubmitQcDate': '2009-04-21', 'lastUpdatePostDateStruct': {'date': '2014-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of interstitial fibrosis/tubular atrophy as defined by Banff interstitial and tubular chronic changes of ci + ct of 2 or more at 6 months', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'The incidence of subclinical rejection at 6 months', 'timeFrame': '6 months'}, {'measure': 'Prevalence of chronic renal histopathology at 24 months', 'timeFrame': '24 months'}, {'measure': 'Renal function as determined by serum creatinine and 24 hour urine creatinine clearance and protein excretion', 'timeFrame': '6, 12 and 24 moths'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Kidney Transplantation', 'Tacrolimus', 'Immunosuppression', 'Graft Survival'], 'conditions': ['Kidney Transplantation']}, 'referencesModule': {'references': [{'pmid': '19935461', 'type': 'BACKGROUND', 'citation': 'Rush DN, Cockfield SM, Nickerson PW, Arlen DJ, Boucher A, Busque S, Girardin CE, Knoll GA, Lachance JG, Landsberg DN, Shapiro RJ, Shoker A, Yilmaz S. Factors associated with progression of interstitial fibrosis in renal transplant patients receiving tacrolimus and mycophenolate mofetil. Transplantation. 2009 Oct 15;88(7):897-903. doi: 10.1097/TP.0b013e3181b723f4.'}]}, 'descriptionModule': {'briefSummary': 'This multicentre randomized, controlled trial (RCT) compared renal allograft histology and function in subjects treated with Tacrolimus + MMF + prednisone undergoing early protocol biopsies and treatment of subclinical rejection versus a non-protocol biopsy control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is the recipient of a first or second cadaveric or living donor mismatched (at least one mismatch) renal transplant\n* If female and of child-bearing potential, subject has a negative pregnancy test and utilizes adequate contraceptive methods\n\nExclusion Criteria:\n\n* Recipients of a kidney from a donor over 65 years of age\n* Recipient of non-related donor kidney with peak pre-transplant PRA \\> 50\n* Subject has lost a previous graft to rejection less than one year from transplant\n* Subject who has received an investigational drug within three months prior to randomization\n* Subjects who are pregnant or breastfeeding\n* Subject receives a kidney lacking a pre-implantation biopsy\n* Subject has significant disease or disability (e.g. malignancy or uncontrolled infection) which prevents adherence to the protocol'}, 'identificationModule': {'nctId': 'NCT00885820', 'briefTitle': 'Benefit of Early Protocol Biopsy and Treatment of Subclinical Rejection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'The Effects of Treatment of Subclinical Rejection on Renal Histology and Graft Function in Renal Transplant Patients Receiving Tacrolimus and Mycophenolate Mofetil', 'orgStudyIdInfo': {'id': 'FKC-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Protocol biopsies at 1, 2 and 3 months', 'interventionNames': ['Drug: Tacrolimus', 'Drug: MMF', 'Drug: Corticosteroids (Prednisone)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'No protocol biopsies', 'interventionNames': ['Drug: Tacrolimus', 'Drug: MMF', 'Drug: Corticosteroids (Prednisone)']}], 'interventions': [{'name': 'Tacrolimus', 'type': 'DRUG', 'otherNames': ['Prograf', 'FK506'], 'description': 'Oral', 'armGroupLabels': ['1', '2']}, {'name': 'MMF', 'type': 'DRUG', 'otherNames': ['Cellcept'], 'description': 'Oral', 'armGroupLabels': ['1', '2']}, {'name': 'Corticosteroids (Prednisone)', 'type': 'DRUG', 'otherNames': ['Methylprednisolone', 'Prednisone'], 'description': 'Oral', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304-1510', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': 'T2N 2T9', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T6G 2B7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V5Z 1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V6Z 1Y6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'R3A 1R9', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'L8N 4A6', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'K1H 7W9', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'H1T 2M4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2L 4M1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1R 2J6', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'S7M 0Z9', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}], 'overallOfficials': [{'name': 'Use Central Contact', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma Canada, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Astellas Pharma Canada, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}