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
- Cooperman Barnabas Medical Center — Livingston, New Jersey, United States
Full record on ClinicalTrials.gov
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