Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring
NCT ID: NCT07060716
Last Updated: 2025-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
125 participants
OBSERVATIONAL
2025-09-08
2025-12-31
Brief Summary
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Researchers will compare results of the GraftAssureDx to rejection detected by standard-of-care graft biopsies.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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\. 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.
Exclusion Criteria
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.
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.
18 Years
ALL
No
Sponsors
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Insight Molecular Diagnostics
INDUSTRY
Responsible Party
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Principal Investigators
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Ekkehard Schuetz, MD, PhD
Role: STUDY_CHAIR
Insight Molecular Diagnostics
Locations
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University of Southern California Keck School of Medicine
Los Angeles, California, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor, Scott & White Research Institute
Dallas, Texas, United States
Intermountain Health
Murray, Utah, United States
Institute of Immunology - Transplantation Immunology
Heidelberg, Baden-Wurttemberg, Germany
Charite Universitatsmedizin
Berlin, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CLN-001
Identifier Type: -
Identifier Source: org_study_id
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