RECRUITING

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

Description

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 RejectionCell-free DNA
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Related Conditions:

Kidney Transplant RejectionCell-free DNA

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Kidney Transplant Rejection
Intervention / Treatment

-

Contacts and Locations

Jacksonville

Mayo Clinic in Florida, Jacksonville, Florida, United States, 32224

Tampa

Tampa General Hospital, Tampa, Florida, United States, 33606

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Nashville

Vanderbilt University Medical Center, Nashville, Tennessee, United States, 37232

Murray

Intermountain Health, Murray, Utah, United States, 84107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Insight Molecular Diagnostics,

Ekkehard Schuetz, MD, PhD, STUDY_CHAIR, Insight Molecular Diagnostics

Study Record Dates

2025-12