Donor-Derived Cell-Free DNA Test for Monitoring Kidney Transplants

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

This test will try whether a blood-based donor-derived cell-free DNA (dd-cfDNA) assay can detect rejection in adults who have received a kidney transplant.

Quick facts

• Study type: Observational
• Enrollment: 125 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Insight Molecular Diagnostics (Industry-sponsored)
• Locations: 10 sites (Los Angeles, California and 9 other locations)
• Trial ID: NCT07060716 on ClinicalTrials.gov

What this trial studies

This observational study collects blood and urine from adult kidney transplant recipients and measures donor-derived cell-free DNA using the GraftAssureDx assay. Results will be compared to standard-of-care graft biopsy findings, with blood draws timed within one week of biopsy or at least two days after an uncomplicated biopsy when the blood draw follows the biopsy. The study enrolls adults at least 12 days post-transplant at three U.S. centers and does not alter clinical care. Data will be used to determine how well the dd-cfDNA test corresponds to biopsy-detected rejection.

Who should consider this trial

Good fit: Ideal candidates are adults (18+) at least 12 days after a kidney transplant who can consent, can provide blood and urine samples, and have a graft biopsy within ±1 week of the blood draw per the protocol.

Not a fit: Patients unlikely to benefit include those whose kidney donor was an identical twin, those with another transplanted organ in place, recipients of hematopoietic stem cell or bone marrow grafts, self-reported pregnant individuals, or those without a contemporaneous biopsy sample for comparison.

Why it matters

Potential benefit: If successful, the test could enable earlier, less invasive detection of rejection using a blood sample and reduce reliance on biopsy.

How similar studies have performed: Other observational studies and commercially available dd-cfDNA tests have shown promising results for detecting rejection, though they have not universally replaced biopsy in clinical practice.

Eligibility criteria

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.

Where this trial is running

Los Angeles, California and 9 other locations

• University of Southern California Keck School of Medicine — Los Angeles, California, United States (Active_not_recruiting)
• Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
• Tampa General Hospital — Tampa, Florida, United States (Recruiting)
• Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Active_not_recruiting)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
• Baylor, Scott & White Research Institute — Dallas, Texas, United States (Recruiting)
• Intermountain Health — Murray, Utah, United States (Recruiting)
• Institute of Immunology - Transplantation Immunology — Heidelberg, Baden-Wurttemberg, Germany (Active_not_recruiting)
• Charite Universitatsmedizin — Berlin, Germany (Active_not_recruiting)

Study contacts

• Study coordinator: Robert Rogers, M.S.

Conditions Kidney Transplant Rejection; Cell-free DNA