NCT07060716 Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring
| NCT ID | NCT07060716 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insight Molecular Diagnostics |
| Condition | Kidney Transplant Rejection |
| Study Type | OBSERVATIONAL |
| Enrollment | 125 participants |
| Start Date | 2025-09-08 |
| Primary Completion | 2025-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 125 participants in total. It began in 2025-09-08 with a primary completion date of 2025-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Ekkehard Schuetz, MD, PhD
STUDY CHAIR
Insight Molecular Diagnostics
Frequently Asked Questions
Who can join the NCT07060716 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Kidney Transplant Rejection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07060716 currently recruiting?
Yes, NCT07060716 is actively recruiting participants. Contact the research team at rrogers@imdxinc.com for enrollment information.
Where is the NCT07060716 trial being conducted?
This trial is being conducted at Los Angeles, United States, Jacksonville, United States, Tampa, United States, Cleveland, United States and 6 additional locations.
Who is sponsoring the NCT07060716 clinical trial?
NCT07060716 is sponsored by Insight Molecular Diagnostics. The principal investigator is Ekkehard Schuetz, MD, PhD at Insight Molecular Diagnostics. The trial plans to enroll 125 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.