[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659417":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":32,"studyPopulation":25,"armGroups":33,"interventions":46,"overallOfficials":53,"centralContacts":57,"locations":66,"responsibleParty":82,"collaborators":84,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":90,"sex":96,"minAge":97,"maxAge":25,"enrollmentInfo":98,"targetDuration":25,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":25,"overallStatus":107,"whyStopped":25,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"University of Pennsylvania","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":25},[9,13],{"measure":10,"description":11,"timeFrame":12},"Successful 50% Immunosuppressive CNI reduction","Successful 50% Immunosuppressive CNI reduction: Successful timepoint. protocol-directed 50% immunosuppression (IS) reduction up to the 12 month (\\~52 week).","Up to 12months",{"measure":14,"description":15,"timeFrame":16},"Allograft status: Rejection\u002Fgraft loss","Allograft status: Rejection\u002Fgraft loss: Freedom from Rejection\u002Fgraft loss for 12 months (\\~52 weeks) after study enrollment.\n\nThis endpoint will be the time to first occurrence of any of the following allograft (rejection or organ failure) events:\n\n* Biopsy-proven acute rejection (BPAR)\n* Clinical rejection (rejection treatment administered in the absence of BPAR)\n* Death or graft loss","12 months after study enrollment",[18,22],{"measure":19,"description":20,"timeFrame":21},"Decrease or improvement in renal function","Decrease or improvement in renal function defined as: (baseline eGFR) - (eGFR at 1-year post-randomization).","1 year post randomization",{"measure":23,"description":24,"timeFrame":21},"For those with a baseline eGFR 30-90 mL\u002Fmin\u002F1.73 m2: absence of a 10% or greater decrease in eGFR","• For those with a baseline eGFR 30-90 mL\u002Fmin\u002F1.73 m2: absence of a 10% or greater decrease in eGFR",null,{"allocation":27,"interventionModel":28,"interventionModelDescription":25,"primaryPurpose":29,"observationalModel":25,"timePerspective":25,"maskingInfo":30},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":31,"maskingDescription":25,"whoMasked":25},"NONE","To evaluate the clinical utility of a miRNA-based signature for detecting alloimmune activation and early liver injury, when used in conjunction with conventional biochemical monitoring, to guide calcineurin (CNI) immunosuppression minimization in stable liver transplant recipients transplanted for non-immune liver diseases at least one year after transplantation. This is a multicenter, prospective, open-label, randomized controlled trial in stable liver transplant recipients receiving a CNI-based immunosuppression regimen. Participants will undergo closely monitored immunosuppression minimization with a target reduction of the CNI dose to 50% of the baseline maintenance dose.\n\nParticipants will be randomized in a 1:1 ratio to one of two immunosuppression minimization strategies: (1) guidance by a miRNA-based biomarker in conjunction with conventional biochemical monitoring, or (2) guidance by conventional biochemical monitoring alone.",[34,40],{"label":35,"type":36,"description":37,"interventionNames":38},"miRNA Biomarker-Guided Immunosuppression Minimization","EXPERIMENTAL","Participants undergo CNI dose reduction with immunosuppression minimization guided by a miRNA-based biomarker in conjunction with conventional biochemical monitoring.",[39],"Other: miRNA Biomarker-Guided Immunosuppression Minimization",{"label":41,"type":42,"description":43,"interventionNames":44},"Conventional Biochemical Monitoring-Guided Immunosuppression Minimization","ACTIVE_COMPARATOR","Participants undergo CNI dose reduction with immunosuppression minimization guided by conventional biochemical monitoring alone.",[45],"Other: Conventional Biochemical Monitoring-Guided Immunosuppression Minimization",[47,50],{"type":6,"name":35,"description":48,"armGroupLabels":49,"otherNames":25},"Participants undergo calcineurin inhibitor (CNI) dose reduction with immunosuppression minimization guided by a miRNA-based biomarker in conjunction with conventional biochemical monitoring.",[35],{"type":6,"name":41,"description":51,"armGroupLabels":52,"otherNames":25},"Participants undergo calcineurin inhibitor (CNI) dose reduction with immunosuppression minimization guided by conventional biochemical monitoring alone.",[41],[54],{"name":55,"affiliation":5,"role":56},"Abraham Shaked, MD, PhD","PRINCIPAL_INVESTIGATOR",[58,63],{"name":59,"role":60,"phone":61,"phoneExt":25,"email":62},"Miranda Targum, MHCI","CONTACT","215-217-7054","miranda.targum@pennmedicine.upenn.edu",{"name":64,"role":60,"phone":25,"phoneExt":25,"email":65},"Tracia Debnam, MS","tracia.debnam@nih.gov",[67],{"facility":68,"status":25,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Hospital of the University of Pennsylvania","Philadelphia","Pennsylvania","19104","United States","US",{"type":75,"coordinates":76},"Point",[77,78],-75.16362,39.95238,{"lat":78,"lon":77},[81],{"name":59,"role":60,"phone":61,"phoneExt":25,"email":62},{"type":83,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[85],{"name":86,"class":87},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH","100659417","phase-2-biomarker-guided-reduction-of-immunosuppression-in-liver-transplant-recipients-britre-100659417",false,"NCT07862439","Biomarker-guided Reduction of Immunosuppression in Liver Transplant Recipients (BRITRE)","Biomarker-guided Reduction of Immunosuppression in Liver Transplant Recipients (BRITRE): A PHASE II TRIAL TO ASSESS THE SAFETY OF BIOMARKER GUIDED IMMUNOSUPPRESSION MINIMIZATION IN LIVER TRANSPLANT RECIPIENTS","BRITRE","Inclusion Criteria:\n\n* 1\\. Age \\>18 years old. 2. \\>12 months and \\\u003C 24 months post transplantation. 3. Liver transplant for non-immune liver disease. 4. For participants with HCV (history of HCV or donor with history of HCV): must be HCV PCR negative and have documented history of Sustained Viral Response to antiviral therapy (\\>=12 weeks) or documented, persistent spontaneous clearance of HCV.\n\n  5\\. For participants with HBV: must be controlled with HBV antiviral treatment and anticipate receiving continuing HBV antiviral treatment for the duration of study participation.\n\n  6\\. Receiving maintenance IS with a CNI (tacrolimus, cyclosporin). 7. No history of BPAR in the prior 6 months. 8. Stable immunosuppression for the prior 3 months. 9. No history of chronic rejection. 10. No known clinical history of cirrhosis post-transplant. 11. Liver chemistry tests: total bilirubin, ALT, AST, GGT, and alkaline phosphatase all \\\u003C= ULN for the prior 3 months.\n\n  12\\. Stable renal function, with eGFR \\>= 30 ml\u002Fmin\u002F1.73m2 by CKD-EPI (2021). 13. For participants known to have a history of TB or latent TB infection, documented history of completing appropriate treatment.\n\n  14\\. Participants of childbearing potential must have a negative pregnancy test upon study entry.\n\n  15\\. All participants with reproductive potential, must agree to use FDA approved methods of birth control for the duration of the study (http:\u002F\u002Fwww.fda.gov\u002Fbirthcontrol).\n\n  16\\. Vaccines up to date as per DAIT guidance for patients in interventional transplant trials of investigational immunosuppression.\n\nExclusion Criteria:\n\n1. Inability or unwillingness of a participant to give documented informed consent or comply with the study protocol.\n2. History of retransplantation or multi-organ transplantation.\n3. Split liver transplantation, except when involving a right tri-segment.\n4. Liver transplantation indication of autoimmune disease.\n5. Use of mTOR inhibitor during the prior 3 months.\n6. Any post-transplant diagnosis of malignancy (except basal cell carcinoma of skin) or recurrent hepatocellular carcinoma.\n7. Active, uncontrolled systemic infection at enrollment.\n8. Known history of infection with human immunodeficiency virus (HIV).\n9. Pregnancy, breastfeeding, or plans to become pregnant during the study period.\n10. History of mental illness or substance abuse that could impact study compliance, as judged by the investigator.\n11. Any past or current medical history, physical examination findings, or laboratory test results not specified above, which, in the opinion of the investigator, may present additional risks, hinder compliance, or affect data quality or interpretation for this study.","ALL","18 Years",{"count":99,"type":100},180,"ESTIMATED","INTERVENTIONAL",[103],"PHASE2","Researchers are interested in determining whether it is safe to reduce anti-rejection medication by approximately 50% after liver transplantation and whether special blood tests called biomarkers can identify early signs that the body is starting to attack the new liver before it gets hurt.",[106],"Liver Diseases","NOT_YET_RECRUITING","2026-10-01",{"date":110,"type":111},"2026-10-07","ACTUAL",{"date":113,"type":100},"2027-01",{"date":115,"type":100},"2031-01",{"name":5,"class":6},1]