Actively Recruiting
Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring
Led by Insight Molecular Diagnostics · Updated on 2025-11-19
125
Participants Needed
10
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is 18 years of age or older
- At least 12 calendar days have passed since receiving a kidney transplant
- Participant has provided legally effective informed consent
- Participant agrees to follow all study procedures
- A graft biopsy is obtained within plus or minus 1 week of blood sample collection
- If blood is drawn after biopsy, it is taken at least 2 days after an uncomplicated biopsy procedure
You will not qualify if you...
- Kidney donor is an identical twin of the participant
- Participant has another transplanted organ in place
- Participant has received a hematopoietic stem cell transplant
- Participant has received a bone marrow graft
- Participant is pregnant
- Investigator believes participation would risk data integrity or participant safety
- Sample collected within 48 hours after an invasive graft biopsy
- Sample collected within 30 days after immunosuppressive treatment for biopsy-proven acute rejection
- Sample collected within 30 days after a blood transfusion
- Participant provided another study sample within the past 7 days
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 10 locations
1
University of Southern California Keck School of Medicine
Los Angeles, California, United States, 90033
Active, Not Recruiting
2
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
3
Tampa General Hospital
Tampa, Florida, United States, 33606
Actively Recruiting
4
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
5
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Active, Not Recruiting
6
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
7
Baylor, Scott & White Research Institute
Dallas, Texas, United States, 75246
Actively Recruiting
8
Intermountain Health
Murray, Utah, United States, 84107
Actively Recruiting
9
Institute of Immunology - Transplantation Immunology
Heidelberg, Baden-Wurttemberg, Germany, 69120
Active, Not Recruiting
10
Charite Universitatsmedizin
Berlin, Germany, 10117
Active, Not Recruiting
Research Team
R
Robert Rogers, M.S.
CONTACT
E
Ekkehard Schuetz, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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