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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Mayo Clinic in Florida
  Jacksonville, Florida, United States Recruiting
• Tampa General Hospital
  Tampa, Florida, United States Recruiting
• Cleveland Clinic
  Cleveland, Ohio, United States 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

Study contacts

• Study coordinator: Robert Rogers, M.S.
• Email: rrogers@imdxinc.com
• Phone: 14436258427

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Frexalimab versus tacrolimus to prevent kidney transplant rejection

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• Platelet aggregation for diagnosing acute kidney transplant rejection

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.