Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInsight Molecular Diagnostics
About this trial
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
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- donor-derived cell-free DNA test
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov