[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Insight Molecular Diagnostics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":70},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"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":20,"type":21},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.",[26],"Kidney Transplant",[28,29,30,31,32,33,34],"kidney transplant","dd-cfDNA","cell-free DNA","allograft rejection","donor derived cell-free DNA","kidney rejection","rejection","NOT_YET_RECRUITING","2026-04-27",{"date":38,"type":39},"2026-05-01","ACTUAL",{"date":41,"type":21},"2026-06",{"date":43,"type":21},"2033-06",{"name":45,"class":46},"Insight Molecular Diagnostics","INDUSTRY",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100597609","validation-of-donor-derived-cell-free-dna-dd-cfdna-for-kidney-transplant-monitoring-100597609","NCT07060716","Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring","GraftAssureDx Study: Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring","Inclusion Criteria:\n\n1. Subject is 18 years of age or older\n2. At least 12 calendar days have elapsed since the subject received a kidney transplant.\n3. Subject has provided legally effective informed consent\n4. Subject agrees to comply with all study procedures\n\nExclusion Criteria:\n\n1. Kidney donor is an identical twin of the subject.\n2. The subject has another previously transplanted organ in situ.\n3. Subject has received a hematopoietic stem cell transplant.\n4. Subject has received a bone marrow graft.\n5. Subject has self-reported as pregnant.\n6. In the opinion of the investigator, the subject's participation in the study would pose a risk to data integrity or to the subject's safety and welfare.\n\nSample Inclusion Criteria:\n\n1\\. A graft biopsy is obtained within ±1 week of blood draw.\n\n* If blood draw is obtained after biopsy, blood draw should be taken at least 2 days after an uncomplicated biopsy procedure.\n\nSample Exclusion Criteria:\n\n1. Sample collected from someone that had an invasive graft biopsy ≤ 48 hours prior to blood draw.\n2. Sample collected from subject that received immunosuppressive treatment for biopsy-proven acute rejection ≤ 30 days prior to blood draw\n3. Sample collected from subject that received a blood transfusion ≤ 30 days prior to blood draw.\n4. Sample collected from a subject that provided another sample for the study within the past 7 days.",{"count":55,"type":21},125,"The goal of this observational study is to learn if the donor-derived cell-free DNA (dd-cfDNA) test can assess rejection in kidney transplant recipients. Participants will have blood and urine collected at their study visit.\n\nResearchers will compare results of the GraftAssureDx to rejection detected by standard-of-care graft biopsies.",[58,59],"Kidney Transplant Rejection","Cell-free DNA","RECRUITING","2025-11-18",{"date":63,"type":39},"2025-11-19",{"date":65,"type":39},"2025-09-08",{"date":67,"type":21},"2025-12",{"name":45,"class":46},10,""]