Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2026-02-21 @ 2:54 PM
Study NCT ID:
NCT02963103
Status:
TERMINATED
Last Update Posted:
2016-11-23
First Post:
2016-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Safety and Efficacy of a Tacrolimus Based Immunosuppressive Regimen in Stable Kidney Transplant Recipients Converted From Cyclosporine Based Immunosuppressive Regimen
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016559', 'term': 'Tacrolimus'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'whyStopped': 'Sponsor decision to terminate the study because subject enrollment was difficult.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-22', 'studyFirstSubmitDate': '2016-10-06', 'studyFirstSubmitQcDate': '2016-11-10', 'lastUpdatePostDateStruct': {'date': '2016-11-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in GFR', 'timeFrame': 'Baseline and Week 24', 'description': 'GFR: glomerular filtration rate'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in total cholesterol', 'timeFrame': 'Baseline and Week 24'}, {'measure': 'Change from baseline in Triglycerides', 'timeFrame': 'Baseline and Week 24'}, {'measure': 'Change from baseline in LDL', 'timeFrame': 'Baseline and Week 24', 'description': 'LDL: low density lipoprotein cholesterol'}, {'measure': 'Change from baseline in HDL', 'timeFrame': 'Baseline and Week 24', 'description': 'HDL: high density lipoprotein cholesterol'}, {'measure': 'Change from baseline in the number of antihyperlipidemic drugs', 'timeFrame': 'Baseline and Week 24'}, {'measure': 'Change from baseline in blood pressure', 'timeFrame': 'Baseline and Week 24'}, {'measure': 'Change from baseline in the number of antihypertensive drugs', 'timeFrame': 'Baseline and Week 24'}, {'measure': 'Change from baseline in number of participants who have had hirsutism', 'timeFrame': 'Baseline and Week 24', 'description': "Investigator's judgment"}, {'measure': 'Change from baseline in number of participants who have had gingival hypertrophy', 'timeFrame': 'Baseline and Week 24', 'description': "Investigator's judgment"}, {'measure': 'Overall incidence rate of adverse events', 'timeFrame': 'up to Week 24'}, {'measure': 'Proportion of participants with patient survival', 'timeFrame': 'up to Week 24'}, {'measure': 'Proportion of participants with organ survival', 'timeFrame': 'up to Week 24'}, {'measure': 'Acute rejection rate confirmed by biopsy', 'timeFrame': 'up to Week 24'}, {'measure': 'Ratio of mean dose of cyclosporine to tacrolimus', 'timeFrame': 'up to Week 24'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tacrolimus', 'Kidney transplantation'], 'conditions': ['Kidney Transplantation']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to observe and evaluate the change in renal function following conversion from cyclosporine-based immunosuppressive regimen to tacrolimus-based one.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients received a kidney transplant at least 12 months before enrollment.\n* Patients whose dosage of previous immunosuppressants has not been changed and remained for at least 4 weeks before enrollment, and blood trough level of cyclosporine is 100 to 200 ng/mL.\n* Patients who have the side effects (hypertension, hyperlipidemia, gingival hyperplasia and hypertrichosis/hirsutism) during use of cyclosporine.\n* Serum creatinine \\< 2.3 mg/dl at enrollment\n* Female patients of childbearing potential must have a negative serum pregnancy test prior to enrollment, and agreed to use effective contraception during the trial.\n* Patients considered clinically stable\n\nExclusion Criteria:\n\n* Patients who have previously received an organ transplant other than a kidney.\n* Patients who have had acute transplant rejection within 12 weeks, or acute transplant rejection requiring antilymphocyte therapy within 24 weeks prior to enrollment.\n* Patients newly diagnosed malignant tumors after organ transplant, but the patients treated completely with basal or squamous cell carcinoma of the skin are excepted.\n* Patients who have an underlying disease such as focal segmental glomerulosclerosis (FSGS) or type II membranoproliferative glomerulonephritis (Type II MPGN).\n* Proteinuria \\> 2 g/24 hrs.\n* Patients who have "Creeping creatinine" (a 20% increase in their creatinine for six months before their enrollment).\n* Patients whose Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) is twice higher than the normal range in the center.\n* Patients who have liver cirrhosis.\n* Patients who are pregnant or breastfeeding.\n* Patients who had been HIV-positive.\n* Patients who have a known allergy to Prograf® or its ingredients, steroids or adjuvants.\n* Patients who have an unstable medical condition that may affect the evaluation of the study\'s objectives.\n* Patients who are receiving prohibited concomitant medications or who received those medications within 28 days of their enrollment.\n* Patients who are currently participating in another clinical trial or who received the investigational drug in another trial within 28 days of their enrollment.\n* Patients who are at the risk of drug abuse or mental disorders or communicate difficulties.'}, 'identificationModule': {'nctId': 'NCT02963103', 'briefTitle': 'A Study to Assess the Safety and Efficacy of a Tacrolimus Based Immunosuppressive Regimen in Stable Kidney Transplant Recipients Converted From Cyclosporine Based Immunosuppressive Regimen', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Single-center Pilot Study to Assess the Safety and Efficacy of a Tacrolimus Based Immunosuppressive Regimen in Stable Kidney Transplant Recipients Converted From Cyclosporine Based Immunosuppressive Regimen', 'orgStudyIdInfo': {'id': 'PRG-KT-10-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tacrolimus group', 'description': 'oral', 'interventionNames': ['Drug: Tacrolimus']}], 'interventions': [{'name': 'Tacrolimus', 'type': 'DRUG', 'otherNames': ['Prograf (R)'], 'description': 'Oral', 'armGroupLabels': ['Tacrolimus group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'KR00001', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma Korea, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Korea, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}