Clinical Trial

GraftAssure Lowering Allograft rejeCTIon by Combination- (GALACTIC) Trial

Study acronym: GALACTIC
Not Yet Recruiting
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Summary
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.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2029-12 -> 2032-12 2026-05-02
minor Completion pushed: 2032-12 -> 2033-06 2026-05-02
Trial Details
NCT Number NCT07551531
Lead Sponsor Insight Molecular Diagnostics
Conditions Kidney Transplant
Enrollment 5,000 participants
Start Date 2026-06
Primary Completion 2032-12 (estimated)
Study Completion 2033-06 (estimated)
Updated on ClinicalTrials.gov 2026-07-30