Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-30 @ 5:40 PM
Study NCT ID:
NCT04542733
Status:
RECRUITING
Last Update Posted:
2025-09-04
First Post:
2020-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Everolimus With Reduced-dose Tacrolimus Versus Reduced-dose Tacrolimus and Leflunomide in Treatment of BK Virus Infection in Kidney Transplantation Recipient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068338', 'term': 'Everolimus'}, {'id': 'D000077339', 'term': 'Leflunomide'}], 'ancestors': [{'id': 'D020123', 'term': 'Sirolimus'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007555', 'term': 'Isoxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'All patients met inclusion criteria will be randomized after BK VL not respond to mycophenolic acid and tacrolimus reduction as a run-in phase for 1 month. The intervention arms include everolimus + reduced dose tacrolimus and leflunomide + reduced dose tacrolimus.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-27', 'studyFirstSubmitDate': '2020-08-27', 'studyFirstSubmitQcDate': '2020-09-02', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma BK viral load change', 'timeFrame': '3 months', 'description': '3-month plasma BK viral load change from randomization'}], 'secondaryOutcomes': [{'measure': 'Plasma BK viral load clearance rate', 'timeFrame': '1, 3, 6 months', 'description': 'Percentage of patients who have negative plasma BK virus at specific time point after randomization'}, {'measure': 'Acute rejection rate', 'timeFrame': '6 months'}, {'measure': 'Glomerular filtration rate (GFR) change', 'timeFrame': '3, 6 months', 'description': 'GFR change at specific timepoint after randomization'}, {'measure': 'Chronicity score in kidney allograft', 'timeFrame': '6 months', 'description': "Banff's criteria for allograft biopsy tissue, focus on ci and ct scores ranging from 0 (no chronicity lesion) to 3 (severe chronicity lesion)"}, {'measure': '6-month plasma BK VL', 'timeFrame': '6 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Kidney Transplantation', 'mTOR inhibitor', 'Leflunomide', 'BK virus'], 'conditions': ['Kidney Transplant Infection', 'BK Virus Infection']}, 'descriptionModule': {'briefSummary': 'BK virus infection is one of the causes of renal allograft loss in the current era. Reduction of immunsuppression is the only intervention that prooved to be effective in treating of BK virus in kidney transplant recipient. However, there are evidences from retrospective and prospective studies showed that leflunomide and mTOR inhibitor such as everolimus or sirolimus have positive outcomes in treatment of BK virus in kidney tranplant recipient. The investigators conduct the RCT to compare the efficacy of leflunomide and mTOR inhibitor everolimus, in treatment of BK virus infected patients who do not respond to immunosuppression reduction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Kidney transplant recipients at King Chulalongkorn Memorial Hospital\n* age \\>= 18 years\n* persistent BK viremia \\>1000 copies/mL at least 2 times in 3 weeks or single time \\> 10000 copies/mL\n\nExclusion Criteria:\n\n* BK VL \\>10\\^5 log\n* Previous BKVAN treatment\n* Drug hypersensitivity to mTORi or leflunomide'}, 'identificationModule': {'nctId': 'NCT04542733', 'acronym': 'ELF', 'briefTitle': 'The Efficacy of Everolimus With Reduced-dose Tacrolimus Versus Reduced-dose Tacrolimus and Leflunomide in Treatment of BK Virus Infection in Kidney Transplantation Recipient', 'organization': {'class': 'OTHER', 'fullName': 'King Chulalongkorn Memorial Hospital'}, 'officialTitle': 'The Efficacy of Everolimus With Reduced-dose Tacrolimus Versus Reduced-dose Tacrolimus and Leflunomide in Treatment of BK Virus Infection in Kidney Transplantation Recipient', 'orgStudyIdInfo': {'id': 'CUKT02/63'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'mTORi with reduced-dose tacrolimus', 'description': 'Patient will received everolimus with target trough concentration of 3-6 ng/mL and tacrolimus with target trough concentration of 2-4 ng/mL. Duration for this regimen would be at least 3 months.', 'interventionNames': ['Drug: Everolimus']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'reduced-dose tacrolimus and Leflunomide', 'description': 'Patient will receive tacrolimus with target concentration of 3-6 ng/mL with leflunomide 100 mg/day loading dose for 5 days, followed by 40 mg/day thereafter. Duration for this regimen would be at least 3 months.', 'interventionNames': ['Drug: reduced dose tacrolimus and Leflunomide']}], 'interventions': [{'name': 'Everolimus', 'type': 'DRUG', 'description': 'Everolimus will be given with tacrolimus.', 'armGroupLabels': ['mTORi with reduced-dose tacrolimus']}, {'name': 'reduced dose tacrolimus and Leflunomide', 'type': 'DRUG', 'description': 'Reduced dose tacrolimus will be given with leflunomide', 'armGroupLabels': ['reduced-dose tacrolimus and Leflunomide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10330', 'city': 'Bangkok', 'state': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Suwasin Udomkarnjananun, M.D.', 'role': 'CONTACT', 'email': 'suwasin.u@gmail.com', 'phone': '66899679885'}], 'facility': 'King Chulalongkorn Memorial Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Suwasin Udomkarnjananun, MD, MSc', 'role': 'CONTACT', 'email': 'suwasin.u@gmail.com', 'phone': '+66899679885'}], 'overallOfficials': [{'name': 'Suwasin Udomkarnjananun, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chulalongkorn University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Chulalongkorn Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Suwasin Udomkarnjananun', 'investigatorAffiliation': 'King Chulalongkorn Memorial Hospital'}}}}