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.
This is a prospective, multi-center, longitudinal, registry study. The study will be conducted in two parts: Part 1: GraftAssureCore assay (Laboratory-Developed Test) Blood samples will be obtained by the site, or via contracted phlebotomy or laboratory services, and shipped to iMDx for centralized GraftAssure testing. Results will be reported to the study site. Part 2: GraftAssureDx assay (On-Site Testing at study site) Sites will be trained to perform on-site GraftAssure testing in-house with iMDx permission, post-FDA authorization.
Study Type
OBSERVATIONAL
Enrollment
5,000
Cooperman Barnabas Medical Center
Livingston, New Jersey, United States
Detect Rejection
Detection of rejection using fractional abundance (%) dd-cfDNA, absolute (cp/mL) dd-cfDNA, and a Combination Model-score of both of these values.
Time frame: 7 years
Validate Superiority of Combination Model-score (CM-score)
Validate superiority of combined use of percent \& cp/mL dd-cfDNA values, defined as Combination Model-score, over individual dd-cfDNA percent and cp/mL values.
Time frame: 7 years
Association of dd-cfDNA levels
Association of dd-cfDNA levels and graft survival/retained function, retransplant, DSA development, and patient survival.
Time frame: 7 years
Graft survival
Graft survival
Time frame: 7 years
Biopsy rate and yield
Time frame: 7 years
Time-to-intervention impact
Lower hospitalization rates, less severe rejection, lower treatment intensity.
Time frame: 7 years
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