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GraftAssure Lowering Allograft rejeCTIon by Combination- (GALACTIC) Trial

NCT07551531 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 5000

Last updated 2026-07-30

No results posted yet for this study

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.

Conditions

  • Kidney Transplant

Sponsors & Collaborators

  • Insight Molecular Diagnostics

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2032-12-31
Completion
2033-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07551531 on ClinicalTrials.gov