NCT07060716 · Insight Molecular Diagnostics
Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring
What this study 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.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Subject is 18 years of age or older
- At least 12 calendar days have elapsed since the subject received a kidney transplant.
- Subject has provided legally effective informed consent
- Subject agrees to comply with all study procedures
Exclusion criteria
- Kidney donor is an identical twin of the subject.
- The subject has another previously transplanted organ in situ.
- Subject has received a hematopoietic stem cell transplant.
- Subject has received a bone marrow graft.
- Subject has self-reported as pregnant.
- 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:
- Sample collected from someone that had an invasive graft biopsy ≤ 48 hours prior to blood draw.
- Sample collected from subject that received immunosuppressive treatment for biopsy-proven acute rejection ≤ 30 days prior to blood draw
- Sample collected from subject that received a blood transfusion ≤ 30 days prior to blood draw.
- Sample collected from a subject that provided another sample for the study within the past 7 days.
Where
- Los Angeles, California
- Jacksonville, Florida
- Tampa, Florida
- Cleveland, Ohio
- Pittsburgh, Pennsylvania
- Nashville, Tennessee
- Dallas, Texas
- Murray, Utah
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 19, 2025 · Source of record for eligibility and locations