Recruiting

dd-cfDNA

Sponsor:

Insight Molecular Diagnostics

Code:

NCT07060716

Conditions

Kidney Transplant Rejection

Cell-free DNA

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

donor-derived cell-free DNA test

Study Details

Brief summary:

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.

Conditions

Kidney Transplant Rejection

Cell-free DNA

Study ID

NCT07060716

Start date

Sep 8, 2025

Status verified date

Nov, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Nov 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Subject is 18 years of age or older
2. At least 12 calendar days have elapsed since the subject received a kidney transplant.
3. Subject has provided legally effective informed consent
4. Subject agrees to comply with all study procedures

Exclusion Criteria:

1. Kidney donor is an identical twin of the subject.
2. The subject has another previously transplanted organ in situ.
3. Subject has received a hematopoietic stem cell transplant.
4. Subject has received a bone marrow graft.
5. Subject has self-reported as pregnant.
6. In the opinion of the investigator, the subject's participation in the study would pose a risk to data integrity or to the subject's safety and welfare.

Sample Inclusion Criteria:

1\. A graft biopsy is obtained within ±1 week of blood draw.

  • If blood draw is obtained after biopsy, blood draw should be taken at least 2 days after an uncomplicated biopsy procedure.

Sample Exclusion Criteria:

1. Sample collected from someone that had an invasive graft biopsy ≤ 48 hours prior to blood draw.
2. Sample collected from subject that received immunosuppressive treatment for biopsy-proven acute rejection ≤ 30 days prior to blood draw
3. Sample collected from subject that received a blood transfusion ≤ 30 days prior to blood draw.
4. Sample collected from a subject that provided another sample for the study within the past 7 days.

Study Design

Enrollment

125 participants

Anticipated

Interventions and Outcome Measures

Interventions

donor-derived cell-free DNA 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.

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. ]
  • Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejection [ Time Frame: Samples tested after the final assay cutoffs have been established will be analyzed to demonstrate clinical performance of the investigational assay. This testing will occur from enrollment to 24 weeks after acquisition of the samples. ]
  • Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejection [ Time Frame: Samples tested after the assay final cutoffs have been established will be analyzed to demonstrate clinical performance of the investigational assay. This testing will occur from enrollment to 24 weeks after acquisition of the samples. ]
  • Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejection [ Time Frame: Samples tested after the final assay cutoffs have been established will be analyzed to demonstrate clinical performance of the investigational assay. This testing will occur from enrollment to 24 weeks after acquisition of the samples. ]
  • Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejection [ Time Frame: Samples tested after the final assay cutoffs have been established will be analyzed to demonstrate clinical performance of the investigational assay. This testing will occur from enrollment to 24 weeks after acquisition of the samples. ]

Central Contacts and Locations

Central contacts

Robert Rogers, M.S.

14436258427rrogers@imdxinc.com

Ekkehard Schuetz, MD, PhD

615-927-1528eschuetz@imdxinc.com

Locations

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Carla Palmucci

904-953-3182Palmucci.Carla@mayo.edu

Principal Investigator:

Mohamed Elrefaei, MD, PhD

Tampa General Hospital

Recruiting

Tampa, Florida, United States, 33606

Contacts

Anelys Marin, B.S.

813-844-2673research@tgh.org

Sandra Sanchez

slsanchez@tgh.org

Principal Investigator:

Suzane Gilbert, MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Jennifer Seaman-Czerr

216-990-0436Czerrj@ccf.org

Principal Investigator:

Ziad Zaky, MD

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Keyann Reaves

615-936-0695Keyann.d.reaves@vumc.org

Principal Investigator:

Anthony Langone, MD

Baylor, Scott & White Research Institute

Recruiting

Dallas, Texas, United States, 75246

Contacts

Eric Javier Martinez, MD

214-820-2050Eric.Martinez1@BSWHealth.org

Ashley McAllister

214-820-1710Ashley.McAllister@BSWHealth.org

Intermountain Health

Recruiting

Murray, Utah, United States, 84107

Contacts

Shannon Sell

801-507-8390Shannon.sell@imail.org

Principal Investigator:

Sanjiv Anand, MD

More Information

Sponsor

Insight Molecular Diagnostics

Last update posted

Nov 19, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Insight Molecular Diagnostics on 2025-11-19.