GraftAssure Lowering Allograft rejeCTIon by Combination- (GALACTIC) Trial

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

• 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.

Inclusion criteria

Historical Control Participant

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

Exclusion criteria

Prospective Participant

• 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.
• Has a current malignancy, other than low-grade malignancy.
• Actively enrolled in another cfDNA assay-based trial.
• 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

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