GraftAssure Lowering Allograft rejeCTIon by Combination- (GALACTIC) Trial

GraftAssure Lowering Allograft rejeCTIon by Combination- (GALACTIC) Trial: A Multi-Center Registry Study Assessing Transplanted Kidney Status

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.

Inclusion Criteria: Prospective Participant

1. 18 years of age or older.
2. ≥ 2 weeks post-kidney transplant at the time of first sample collection.
3. Provides legally effective informed consent.
4. Agrees to comply with all study procedures.

Inclusion Criteria: Historical Control Participant

1. 18 years of age or older
2. Has a minimum of three clinical evaluations per year post-transplant.

Exclusion Criteria: Prospective Participant

1. Has received transplanted kidney from their identical twin.
2. Has a history of another previously transplanted organ in situ, other than a prior kidney transplant.
3. Has received an allogenic bone marrow graft or hematopoietic stem cell transplantation (HSCT).
4. Self-reports as pregnant.
5. Has a current malignancy, other than low-grade malignancy.
6. Actively enrolled in another cfDNA assay-based trial.
7. In the opinion of the investigator, participation in this study would pose a risk to data integrity or to the participant's safety and welfare.

Exclusion Criteria: Historical Control Participant

1. Has received a kidney transplant from their identical twin.
2. Has a history of another previously transplanted organ in situ, excluding previous kidney transplant.
3. Has a current malignancy, other than low-grade malignancy.
4. Self-reported pregnancy during the historical data time period.