Cell-free DNA, Kidney Transplant Rejection
Conditions
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.
Interventions
DIAGNOSTIC_TESTdonor-derived cell-free DNA test
A donor-derived cell-free DNA (dd-cfDNA) test used to measure the concentration of total cell-free DNA and the fractional abundance of the dd-cfDNA.
Sponsors
Insight Molecular Diagnostics
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejection | Samples tested after final assay cutoffs have been established will be analyzed to demonstrate clinical performance of the investigational assay. This testing will occur from enrollment to 18 weeks after acquisition of the samples. | Relative percentage of dd-cfDNA levels of 0.5% and absolute values of 50cp/mL are considered to be the diagnostic cutoff for rejection, which will be refined during the first study phase. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ROC-AUC of dd-cfDNA vs. biopsy-confirmed rejection. | This testing will occur from assay cutoff up to 24 weeks after acquisition of the samples. | The second endpoint is for investigational use only and therefore has no predefined success criteria. |
| Correlation between GraftAssureDx results and traditional biomarkers of kidney rejection (creatinine, estimated glomerular filtration rate, blood urea nitrogen). | This testing will occur from assay cutoff up to 24 weeks after acquisition of the samples. | The second endpoint is for investigational use only and therefore has no predefined success criteria. |
Countries
Germany, United States
Contacts
Primary ContactRobert Rogers, M.S.
Backup ContactEkkehard Schuetz, MD, PhD
Outcome results
None listed