[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635349":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":12,"locations":10,"responsibleParty":22,"collaborators":10,"id":24,"slug":25,"hasResults":26,"nctId":27,"briefTitle":28,"officialTitle":29,"acronym":30,"eligibilityCriteria":31,"healthyVolunteers":26,"sex":32,"minAge":33,"maxAge":10,"enrollmentInfo":34,"targetDuration":37,"studyType":38,"phases":10,"briefSummary":39,"conditions":40,"keywords":42,"overallStatus":50,"whyStopped":10,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":10},{"fullName":5,"class":6},"Insight Molecular Diagnostics","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Kidney transplant recipients",null,"Adult kidney transplant recipients at least 2 weeks post-kidney transplant",[13,18],{"name":14,"role":15,"phone":16,"phoneExt":10,"email":17},"Annum Zhara, MSc.","CONTACT","1-949-554-4946","azhara@imdxinc.com",{"name":19,"role":15,"phone":20,"phoneExt":10,"email":21},"Nick Ioannou, MD, PHD, MHA","630-596-3332","nioannou@imdxinc.com",{"type":23,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100635349","graftassure-lowering-allograft-rejection-by-combination--galactic-trial-100635349",false,"NCT07551531","GraftAssure Lowering Allograft rejeCTIon by Combination- (GALACTIC) Trial","GraftAssure Lowering Allograft rejeCTIon by Combination- (GALACTIC) Trial: A Multi-Center Registry Study Assessing Transplanted Kidney Status","GALACTIC","Inclusion Criteria: Prospective Participant\n\n1. 18 years of age or older.\n2. ≥ 2 weeks post-kidney transplant at the time of first sample collection.\n3. Provides legally effective informed consent.\n4. Agrees to comply with all study procedures.\n\nInclusion Criteria: Historical Control Participant\n\n1. 18 years of age or older\n2. Has a minimum of three clinical evaluations per year post-transplant.\n\nExclusion Criteria: Prospective Participant\n\n1. Has received transplanted kidney from their identical twin.\n2. Has a history of another previously transplanted organ in situ, other than a prior kidney transplant.\n3. Has received an allogenic bone marrow graft or hematopoietic stem cell transplantation (HSCT).\n4. Self-reports as pregnant.\n5. Has a current malignancy, other than low-grade malignancy.\n6. Actively enrolled in another cfDNA assay-based trial.\n7. In the opinion of the investigator, participation in this study would pose a risk to data integrity or to the participant's safety and welfare.\n\nExclusion Criteria: Historical Control Participant\n\n1. Has received a kidney transplant from their identical twin.\n2. Has a history of another previously transplanted organ in situ, excluding previous kidney transplant.\n3. Has a current malignancy, other than low-grade malignancy.\n4. Self-reported pregnancy during the historical data time period.","ALL","18 Years",{"count":35,"type":36},5000,"ESTIMATED","3 Years","OBSERVATIONAL","The GALACTIC Registry study purpose is to validate the Combination Model-score (CM-score) for increased accuracy in the percentage of the positive predictive value (PPV) of allograft rejection results for the GraftAssure (GraftAssureCore and GraftAssureDx) assay. This will also be correlated with the biopsy yield and treatment decisions. The GraftAssure assay is a diagnostic test intended for the quantitative measurement of dd-cfDNA in plasma from kidney transplant recipients. The test is minimally invasive, and is intended to be used in conjunction with standard clinical assessment and other laboratory findings as an aid in the detection of allograft rejection.",[41],"Kidney Transplant",[43,44,45,46,47,48,49],"kidney transplant","dd-cfDNA","cell-free DNA","allograft rejection","donor derived cell-free DNA","kidney rejection","rejection","NOT_YET_RECRUITING","2026-04-27",{"date":53,"type":54},"2026-05-01","ACTUAL",{"date":56,"type":36},"2026-06",{"date":58,"type":36},"2033-06",{"name":5,"class":6}]