GraftAssure Lowering Allograft rejeCTIon by Combination- (GALACTIC) Trial

Starting soon

Conditions studied: Kidney Transplant

In brief

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.

Key facts

Study ID
NCT07551531
Run by
Insight Molecular Diagnostics
People needed
5000
Starts
2026-06-01
Expected to finish
2033-06-01
Last updated by the study team
2026-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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