[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100472506":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":25,"locations":34,"responsibleParty":57,"collaborators":25,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":25,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":84,"whyStopped":25,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"University of Florida","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Physician Dosing","ACTIVE_COMPARATOR","Subjects will continue per SOC, where the management of their immunosuppression regimen will be determined by their physician per center practices, including dd-cfDNA data.",[13],"Other: Standard of Care Dosing",{"label":15,"type":16,"description":17,"interventionNames":18},"PPM Dosing","EXPERIMENTAL","Subjects will have dd-cfDNA data analyzed by PPM. Data, such as drug levels and regimens, will be used to fit a 2nd order polynomial for each patient to build patient-specific dose-response profiles with covariates that include the administered drugs tacrolimus, steroids, and MMF\u002FMPA. PPM will be used to derive an optimal combination of tacrolimus, MMF\u002FMPA, and prednisone to achieve minimal renal allograft injury, while staying within the therapeutic range of the medications. All else being equal, the most efficacious combination with the lowest dose of tacrolimus will be utilized.",[19],"Other: Phenotypic Personalized Medicine Dosing",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Phenotypic Personalized Medicine Dosing","Phenotypic Personalized Medicine (PPM) will mediate mechanism-independent and patient specific optimization of immunosuppression. We have developed a powerful platform that allows the provider to use clinical data to construct a Parabolic Response Surface (PRS). Using this visualization of the data, the provider can them make a decision on the optimal combination of drug doses needed to achieve the desired outcome.",[15],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Standard of Care Dosing","Providers will decide on the combination of drug doses needed based on their overall assessment per standard of care.",[9],[31],{"name":32,"affiliation":5,"role":33},"Ali Zarrinpar, MD PhD","PRINCIPAL_INVESTIGATOR",[35],{"facility":36,"status":25,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"University of Florida Health Shands","Gainesville","Florida","32610","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-82.32483,29.65163,{"lat":46,"lon":45},[49,53],{"name":32,"role":50,"phone":51,"phoneExt":25,"email":52},"CONTACT","352-265-0606","ali.zarrinpar@surgery.ufl.edu",{"name":54,"role":50,"phone":55,"phoneExt":25,"email":56},"Alfonso Santos, MD","(352) 273-8821","Alfonso.Santos@medicine.ufl.edu",{"type":58,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100472506","aiim-trial-personalized-medicine-approach-to-kidney-allograft-function-100472506",false,"NCT05432765","AIIM Trial: Personalized Medicine Approach to Kidney Allograft Function","AIIM Trial: Protecting Kidney Function After Transplantation Using Augmented Intelligence Based Immunosuppression Dosing","AIIM","Inclusion Criteria:\n\n* Adult (18 years of age or older) patients with end-stage renal disease (ESRD)\n* Recipient of a first or subsequent deceased donor kidney transplant\n* Clinical indication to receive tacrolimus as the primary immunosuppression\n* Willing and able to provide written informed consent to participate\n\nExclusion Criteria:\n\n* Recipients of transplanted organs other than kidney\n* Recipients of a transplant from a monozygotic (identical) sibling\n* Human Leukocyte Antigen (HLA)-identical donor (zero out of six antigen mismatch donor)\n* Recipient of third or more transplant\n* Current or historical panel reactive antibodies of more than 50%\n* Blood Type (ABO) incompatibility or known moderate or strong donor specific antibodies\n* De novo or recurrent glomerulonephritis on 3-month biopsy\n* Lupus nephritis on 3-month biopsy\n* Focal segmental glomerulosclerosis on 3-month biopsy\n* BK polyomavirus nephropathy in current or prior transplant\n* Recipient of a bone marrow transplant\n* Recipient who is pregnant\n* Enrollment in a competing trial that would interfere with selection or alteration of immunosuppression\n* Inability to follow up with transplant center for up to 15 months after transplantation\n* Anticipated major surgery during the time of planned study\n* Major medical illness with life expectancy less than 15 months\n* Suspicion of noncompliance\n* Anticipated relocation to a location that would not allow follow up at local center in the next 18 months\n* Inability to tolerate normal range levels of tacrolimus","ALL","18 Years","99 Years",{"count":71,"type":72},34,"ESTIMATED","INTERVENTIONAL",[75],"NA","The objective of the proposed study it to perform a pilot clinical trial both to establish feasibility of applying a computational, augmented intelligence based approach, Phenotypic Precision Medicine (PPM), to optimizing combination drug therapy and to gather preliminary data to support a larger fully powered multi-center clinical trial. The key rationale for this clinical selection is that we have the technical, biological, and medical expertise in this disease, a wealth of experience in the use of PPM in both in vitro and the clinical setting, and a robust and integrated transplant program with a well-functioning clinical trial infrastructure.",[78],"Kidney Transplant Rejection",[80,81,82,83],"Kidney","Transplant","dd-cf DNA","Personalized Medicine","NOT_YET_RECRUITING","2026-02-09",{"date":87,"type":88},"2026-02-10","ACTUAL",{"date":90,"type":72},"2026-12",{"date":92,"type":72},"2031-01-01",{"name":5,"class":6},1]