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A Multicenter, Prospective Blood Collection Study in a Kidney Transplant Population

RecruitingN/A

Sponsor: Devyser Inc.

Conditions: Kidney Disease, Kidney Transplant, Transplant Recipient, Renal Function, Cell-free DNA

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

1. Willing and able to provide written informed consent
2. Is 18 years of age or older at enrollment
3. Had a kidney transplant prior to enrollment
4. Is having an indication (for cause) biopsy as determined by clinician
5. retrospective leftover samples are available from the kidney donor(s).

Exclusion Criteria:

1. Is pregnant
2. Had a blood transfusion within the past 4 weeks
3. Had a transplant from an identical (monozygotic) twin
4. Had transplants of multiple organs from the same donor (eg, kidney and liver transplant).
5. Had transplants of more than 2 organs from different donors (eg, recipient of a third kidney transplant)
6. Had a transplant of hematopoietic stem cells (eg, bone marrow) or tissue (eg, heart valve)

Locations (6)

San Diego, California, United States
San Francisco, California, United States
Atlanta, Georgia, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Salt Lake City, Utah, United States