GraftAssure Lowering Allograft rejeCTIon by Combination- (GALACTIC) Trial
ConditionKidney Transplant
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInsight Molecular Diagnostics
About this trial
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.
Eligibility criteria
Qualifiers
18 years of age or older.
≥ 2 weeks post-kidney transplant at the time of first sample collection.
Provides legally effective informed consent.
Agrees to comply with all study procedures.
Disqualifiers
Has received transplanted kidney from their identical twin.
Has a history of another previously transplanted organ in situ, other than a prior kidney transplant.
Has received an allogenic bone marrow graft or hematopoietic stem cell transplantation (HSCT).
Self-reports as pregnant.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
5,000 Participants
are grouped into 1 trial groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov