Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring

Part of paid clinical trials in Los Angeles, California.

Sponsor
Insight Molecular Diagnostics
Study ID
NCT07060716
Status
Recruiting
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Conditions

  • Cell-free DNA
  • Kidney Transplant Rejection

Eligibility Criteria

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

Interventions

  • donor-derived cell-free DNA test — DIAGNOSTIC_TEST
    A donor-derived cell-free DNA (dd-cfDNA) test used to measure the concentration of total cell-free DNA and the fractional abundance of the dd-cfDNA.

Study Details

The goal of this observational study is to learn if the donor-derived cell-free DNA (dd-cfDNA) test can assess rejection in kidney transplant recipients. Participants will have blood and urine collected at their study visit. Researchers will compare results of the GraftAssureDx to rejection detected by standard-of-care graft biopsies.

Key Dates

Start date
Sep 8, 2025
Status verified
Nov 2025
Primary completion
Nov 30, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
125 participants (estimated)

Primary Outcome Measure

Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejection [ Time Frame: Samples tested after final assay cutoffs have been established will be analyzed to demonstrate clinical performance of the investigational assay. This testing will occur from enrollment to 18 weeks after acquisition of the samples. ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
University of Southern California Keck School of MedicineLos AngelesCalifornia90033-
Mayo Clinic in FloridaJacksonvilleFlorida32224
Carla Palmucci
[email protected]
904-953-3182
Mohamed Elrefaei, MD, PhD (PRINCIPAL_INVESTIGATOR)
Tampa General HospitalTampaFlorida33606
Anelys Marin, B.S.
[email protected]
813-844-2673
Sandra Sanchez
[email protected]
Suzane Gilbert, MD (PRINCIPAL_INVESTIGATOR)
Cleveland ClinicClevelandOhio44195
Jennifer Seaman-Czerr
[email protected]
216-990-0436
Ziad Zaky, MD (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Medical CenterPittsburghPennsylvania15213-
Vanderbilt University Medical CenterNashvilleTennessee37232
Keyann Reaves
[email protected]
615-936-0695
Anthony Langone, MD (PRINCIPAL_INVESTIGATOR)
Baylor, Scott & White Research InstituteDallasTexas75246
Eric Javier Martinez, MD
[email protected]
214-820-2050
Ashley McAllister
[email protected]
214-820-1710
Intermountain HealthMurrayUtah84107
Shannon Sell
[email protected]
801-507-8390
Sanjiv Anand, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
University of Southern California Keck School of Medicine· Los Angeles, CAMayo Clinic in Florida· Jacksonville, FLTampa General Hospital· Tampa, FLCleveland Clinic· Cleveland, OHUniversity of Pittsburgh Medical Center· Pittsburgh, PAVanderbilt University Medical Center· Nashville, TN

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