[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648382":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":11,"centralContacts":23,"locations":11,"responsibleParty":28,"collaborators":11,"id":30,"slug":31,"hasResults":32,"nctId":33,"briefTitle":34,"officialTitle":35,"acronym":36,"eligibilityCriteria":37,"healthyVolunteers":32,"sex":38,"minAge":39,"maxAge":11,"enrollmentInfo":40,"targetDuration":11,"studyType":43,"phases":44,"briefSummary":46,"conditions":47,"keywords":50,"overallStatus":52,"whyStopped":11,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":11},{"fullName":5,"class":6},"Natera, Inc.","INDUSTRY",[8,12],{"label":9,"type":10,"description":11,"interventionNames":11},"Control Arm","NO_INTERVENTION",null,{"label":13,"type":14,"description":11,"interventionNames":15},"Test Arm","ACTIVE_COMPARATOR",[16],"Diagnostic Test: Prospera Immunosuppression Optimization",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":11},"DIAGNOSTIC_TEST","Prospera Immunosuppression Optimization","The test arm will include participants who are managed with routine clinical care, along with a standardized dd-cfDNA protocol, to guide optimization of immunosuppression dosages.",[13],[24],{"name":5,"role":25,"phone":26,"phoneExt":11,"email":27},"CONTACT","650-273-4468","impakt@natera.com",{"type":29,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100648382","immunosuppression-optimization-using-the-prospera-assay-in-kidney-transplant-recipients-impakt-100648382",false,"NCT07718633","Immunosuppression Optimization Using The Prospera Assay In Kidney Transplant Recipients (IMPAKT)","Immunosuppressant optiMization Using the Prospera Assay in Kidney Transplant (IMPAKT) Randomized Controlled Trial","IMPAKT","Inclusion Criteria:\n\n* Subjects received a kidney transplant in the prior 3 months.\n* Subjects receiving maintenance therapy consisting of tacrolimus, mycophenolate sodium or mycophenolate mofetil, and optionally corticosteroids, at the time of enrollment.\n* Subjects received induction therapy comprising IL2 receptor antagonist or thymoglobulin, or received no induction therapy.\n* 18 years of age or older at time of signing informed consent.\n* Able to read, understand and provide written informed consent, and willing and able to comply with the study requirements. If the subject is unable to sign the informed consent, a legally authorized representative (LAR) can consent on behalf of the subject.\n* Subjects are at the site standard-of-care MPA dosage\n\nExclusion Criteria:\n\n* Concurrent multiple solid organ or tissue transplants.\n* History of a previous organ transplant (aside from present kidney transplant), or cellular transplant.\n* DSA Positive according to local protocol, including either pre-transplant DSA positivity and de novo DSA positivity.\n* Any prior dd-cfDNA results ≥1.0% or ≥78cp\u002FmL after 28 days post-transplant.\n* ABO Incompatible donor.\n* A serious medical condition that may adversely affect ability to participate in the study (e.g, current diagnosis of cancer).\n* Pregnancy.\n* Received any induction therapy other than IL2 receptor antagonist or thymoglobulin.\n* Receiving any maintenance immunosuppression other than tacrolimus, mycophenolate sodium or mycophenolate mofetil, and prednisone.\n* Currently undergoing regular dialysis.\n* Considered high-risk at the time of enrollment, as per the treating physician.\n* Planned or ongoing use of other commercially available or investigational dd-cfDNA or blood-based gene expression profile assays for rejection surveillance, through randomization.","ALL","18 Years",{"count":41,"type":42},750,"ESTIMATED","INTERVENTIONAL",[45],"NA","IMPAKT is a research study that looks at whether a blood test called Prospera™ can help doctors better adjust anti-rejection medications, compared to the usual way doctors manage these medications without using this test.",[48,49],"Kidney Transplant","Immunosuppresion",[48,51],"Immunosuppression","NOT_YET_RECRUITING","2026-07-17",{"date":55,"type":56},"2026-07-22","ACTUAL",{"date":58,"type":42},"2026-07",{"date":60,"type":42},"2031-07",{"name":5,"class":6}]