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GraftAssure Lowering Allograft rejeCTIon by Combination- (GALACTIC) Trial
Sponsor: Insight Molecular Diagnostics
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.
Official title: GraftAssure Lowering Allograft rejeCTIon by Combination- (GALACTIC) Trial: A Multi-Center Registry Study Assessing Transplanted Kidney Status
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
5000
Start Date
2026-04
Completion Date
2032-12
Last Updated
2026-04-27
Healthy Volunteers
No