GraftAssure Lowering Allograft rejeCTIon by Combination- (GALACTIC) Trial

Part of paid clinical trials in Livingston, New Jersey.

Sponsor
Insight Molecular Diagnostics
Study ID
NCT07551531
Status
Not Yet Recruiting

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Conditions

  • Kidney Transplant

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Apr 27, 2026
Start date
Jun 30, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2032
Completion
Jun 30, 2033

Study Design

Enrollment
5,000 participants (estimated)

Arms

  • Arm: Kidney transplant recipients
    Adult kidney transplant recipients at least 2 weeks post-kidney transplant

Primary Outcome Measure

Detect Rejection [ Time Frame: 7 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cooperman Barnabas Medical CenterLivingstonNew Jersey07039
Ana Merced Director of Transplant Services, PhD, MSN, RN, BS, CCTC
[email protected]
973-322-8467
Anup Patel, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Cooperman Barnabas Medical Center· Livingston, NJ

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