Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-01-24 @ 4:53 AM
Study NCT ID:
NCT03828058
Status:
COMPLETED
Last Update Posted:
2021-01-12
First Post:
2018-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Envarsus XL Immunosuppression Following Liver Transplantation
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The study will be a prospective, randomized, open label study comparing Envarsus XR with twice daily prograf.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-11', 'studyFirstSubmitDate': '2018-12-11', 'studyFirstSubmitQcDate': '2019-01-31', 'lastUpdatePostDateStruct': {'date': '2021-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in estimated glomerular filtration rate (eGFR) over the first year after liver transplant', 'timeFrame': '3, 6, and 12 months post-transplant', 'description': 'We will be assessing differences in renal function based on calculated eGFR by MDRD6 equation.'}], 'secondaryOutcomes': [{'measure': 'Quality of Life Assessment', 'timeFrame': '3, 6, and 12 months post-transplant', 'description': 'We will be using the RAND Short Form 36 (SF36) healthcare survey to assess patient reported quality of life across a broad spectrum ranging from physical health and function to emotional well being. Each sub scale score ranges from 0 (worse) to 100 (best).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Recipients of Liver Transplant']}, 'referencesModule': {'references': [{'pmid': '20532100', 'type': 'BACKGROUND', 'citation': 'Kadam P, Bhalerao S. Sample size calculation. Int J Ayurveda Res. 2010 Jan;1(1):55-7. doi: 10.4103/0974-7788.59946. No abstract available.'}, {'pmid': '22233522', 'type': 'RESULT', 'citation': 'Abdelmalek MF, Humar A, Stickel F, Andreone P, Pascher A, Barroso E, Neff GW, Ranjan D, Toselli LT, Gane EJ, Scarola J, Alberts RG, Maller ES, Lo CM; Sirolimus Liver Conversion Trial Study Group. Sirolimus conversion regimen versus continued calcineurin inhibitors in liver allograft recipients: a randomized trial. Am J Transplant. 2012 Mar;12(3):694-705. doi: 10.1111/j.1600-6143.2011.03919.x. Epub 2012 Jan 10.'}, {'pmid': '7509516', 'type': 'RESULT', 'citation': 'Backman L, Nicar M, Levy M, Distant D, Eisenstein C, Renard T, Goldstein R, Husberg B, Gonwa TA, Klintmalm G. FK506 trough levels in whole blood and plasma in liver transplant recipients. Correlation with clinical events and side effects. Transplantation. 1994 Feb 27;57(4):519-25.'}, {'pmid': '21931704', 'type': 'RESULT', 'citation': 'Kong Y, Wang D, Shang Y, Liang W, Ling X, Guo Z, He X. Calcineurin-inhibitor minimization in liver transplant patients with calcineurin-inhibitor-related renal dysfunction: a meta-analysis. PLoS One. 2011;6(9):e24387. doi: 10.1371/journal.pone.0024387. Epub 2011 Sep 9.'}, {'pmid': '26113208', 'type': 'RESULT', 'citation': 'Langone A, Steinberg SM, Gedaly R, Chan LK, Shah T, Sethi KD, Nigro V, Morgan JC; STRATO Investigators. Switching STudy of Kidney TRansplant PAtients with Tremor to LCP-TacrO (STRATO): an open-label, multicenter, prospective phase 3b study. Clin Transplant. 2015 Sep;29(9):796-805. doi: 10.1111/ctr.12581. Epub 2015 Aug 6.'}, {'pmid': '25539464', 'type': 'RESULT', 'citation': 'Yoo MC, Vanatta JM, Modanlou KA, Campos L, Nezakatgoo N, Nair S, Eason JD. Steroid-free Liver Transplantation Using Rabbit Antithymocyte Globulin Induction in 500 Consecutive Patients. Transplantation. 2015 Jun;99(6):1231-5. doi: 10.1097/TP.0000000000000477.'}, {'pmid': '25613762', 'type': 'RESULT', 'citation': 'Garnock-Jones KP. Tacrolimus prolonged release (Envarsus(R)): a review of its use in kidney and liver transplant recipients. Drugs. 2015 Feb;75(3):309-20. doi: 10.1007/s40265-015-0349-2.'}, {'pmid': '19857743', 'type': 'RESULT', 'citation': 'Niel OR, Berthoux F, Albano L, Dahan P, Aoudia R, Gugenheim J, Cassuto E. Long-term glomerular filtration rate in liver allograft recipients according to the type of calcineurin inhibitors. Transplant Proc. 2009 Oct;41(8):3329-32. doi: 10.1016/j.transproceed.2009.09.034.'}]}, 'descriptionModule': {'briefSummary': 'The standard immunosuppressive regimen for liver transplantation includes twice daily tacrolimus (Prograf). In other transplantation models, there are potential benefits to extended release formulations as lower peak concentrations are thought to have lower rates of nephrotoxicity. Additionally, compliance with once daily medications is felt to be easier than twice daily medications. Our aim is to look at our prospective liver transplant group and see if once daily tacrolimus (Envarsus XR) results in improved renal function as well as improved health care quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female, aged 18 years or older\n4. Recipients of a first-time liver transplant\n5. Serum Creatinine level less than 2.0 on Post-Operative Day 3-7\n6. Ability to take oral medication and be willing to adhere to the assigned immunosuppression regimen\n7. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration\n\nExclusion Criteria:\n\n1. Any prior use of tacrolimus or cyclosporine\n2. Recipients of prior organ transplant\n3. Need for hemodialysis in the week preceding or following liver transplantation\n4. Recipients of living donor liver or split deceased donor liver allografts\n5. Recipients of combined liver/kidney transplants\n6. Pregnancy or lactation\n7. Recipients of ABO incompatible liver allografts'}, 'identificationModule': {'nctId': 'NCT03828058', 'briefTitle': 'Envarsus XL Immunosuppression Following Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Methodist Healthcare'}, 'officialTitle': 'A 12 Month Single-center, Open Label, Randomized, Comparative Study to Evaluate Envarsus XL Steroid-free Rabbit Anti-thymocyte Globulin Induction on Renal Function and Health-related Quality of Life Following Liver Transplantation', 'orgStudyIdInfo': {'id': '18-05876-FB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Envarsus XR', 'description': 'Envarsus XR orally administered Daily', 'interventionNames': ['Drug: Envarsus XR']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prograf', 'description': 'Prograf PO administered twice daily Generic Name: tacrolimus\n\nDosage of prograf will be determined by trough levels and adjusted accordingly', 'interventionNames': ['Drug: Prograf']}], 'interventions': [{'name': 'Envarsus XR', 'type': 'DRUG', 'otherNames': ['ENVARSUS XR 0.75Mg Extended-Release Tablet', 'ENVARSUS XR 1Mg Extended-Release Tablet', 'ENVARSUS XR 4Mg Extended-Release Tablet'], 'description': 'Envarsus XR to be administered orally, once a day. Dosage will be adjusted as determined by trough blood levels.', 'armGroupLabels': ['Envarsus XR']}, {'name': 'Prograf', 'type': 'DRUG', 'otherNames': ['Tacrolimus'], 'description': 'Prograf 2 mg BID to be administered orally, twice a day. Dosage will be adjusted as determined by trough blood levels.', 'armGroupLabels': ['Prograf']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38104', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Methodist Healthcare, University Hospital', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'overallOfficials': [{'name': 'James Eason, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The University of Tennessee Health Science Center, Department of Transplant'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Methodist Healthcare', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}