Overview
The purpose of this research is to collect blood samples and data from kidney transplant patients. The samples and data will be used for research and development of non-invasive test to detect donor-derived cell-free DNA (dd-cfDNA) in kidney transplant patients to evaluate the status of the transplanted organ.
Description
This is a prospective, multicenter sample collection study within a kidney transplant population.
Whole blood samples and clinical data will be obtained from each participant at the time of indication biopsy (prior to the biopsy procedure).
De-identified leftover retrospective gDNA screening samples from the paired donor(s) will also be obtained.
Eligibility
Inclusion Criteria:
- Willing and able to provide written informed consent
- Is 18 years of age or older at enrollment
- Had a kidney transplant prior to enrollment
- Is having an indication (for cause) biopsy as determined by clinician
- retrospective leftover samples are available from the kidney donor(s).
Exclusion Criteria:
- Is pregnant
- Had a blood transfusion within the past 4 weeks
- Had a transplant from an identical (monozygotic) twin
- Had transplants of multiple organs from the same donor (eg, kidney and liver transplant).
- Had transplants of more than 2 organs from different donors (eg, recipient of a third kidney transplant)
- Had a transplant of hematopoietic stem cells (eg, bone marrow) or tissue (eg, heart valve)