Not Yet RecruitingNot Applicable

GraftAssure Lowering Allograft rejeCTIon by Combination- (GALACTIC) Trial

5,000 participantsStarted 2026-06

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

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

Exclusion criteria

✕. 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.
✕. Has received a kidney transplant from their identical twin.

What they're measuring

Detect Rejection

Timeframe: 7 years

Validate Superiority of Combination Model-score (CM-score)

Timeframe: 7 years

Trial details

NCT IDNCT07551531

SponsorInsight Molecular Diagnostics

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2032-12

Contact for this trial

Annum Zhara, MSc.

1-949-554-4946 azhara@imdxinc.com

View on ClinicalTrials.gov More Kidney Transplant trials