GALACTIC Observational Trial, GraftAssure Kidney Transplant, Apr 27
ClinicalTrials.gov Studies
Summary
The GALACTIC Registry study (NCT07551531) is an observational clinical trial evaluating the Combination Model-score (CM-score) for improved accuracy in predicting allograft rejection using the GraftAssure assay (GraftAssureCore and GraftAssureDx) in kidney transplant recipients. The GraftAssure assay measures donor-derived cell-free DNA (dd-cfDNA) in plasma as a minimally invasive aid in detecting transplant rejection. The trial was registered on April 27, 2026.
“The GraftAssure assay is a diagnostic test intended for the quantitative measurement of dd-cfDNA in plasma from kidney transplant recipients.”
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What changed
ClinicalTrials.gov has registered the GALACTIC Registry observational study (NCT07551531), which will validate the CM-score to improve positive predictive value of the GraftAssure dd-cfDNA assay for detecting kidney allograft rejection. The GraftAssure assay is intended for quantitative measurement of donor-derived cell-free DNA in plasma from kidney transplant recipients, used alongside standard clinical assessment.
Affected parties include clinical investigators, transplant centers, and diagnostic laboratories involved in kidney transplant monitoring. The registry entry itself creates no compliance obligations but signals an active validation effort for a diagnostic test that, if successful, may influence rejection-monitoring protocols in transplant care.
Archived snapshot
Apr 27, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
GraftAssure Lowering Allograft rejeCTIon by Combination- (GALACTIC) Trial
Observational NCT07551531 Kind: OBSERVATIONAL Apr 27, 2026
Abstract
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.
Conditions: Kidney Transplant
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