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
This trial does not accept healthy volunteersQualifiers
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 population
Adult kidney transplant recipients across up to 60 student centers in the United States.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
5,000 Participants
are grouped into 1 trial groupGroup A: Kidney transplant recipients
Trial outcomes
Primary outcomes
1
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 years2
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 yearsSecondary outcomes
1
Association of dd-cfDNA levels
Association of dd-cfDNA levels and graft survival/retained function, retransplant, DSA development, and patient survival.
Time frame
7 years2
Graft survival
Graft survival
Time frame
7 years3
Biopsy rate and yield
Time frame
7 years4
Time-to-intervention impact
Lower hospitalization rates, less severe rejection, lower treatment intensity.
Time frame
7 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: