RecruitingNCT07006831

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

Sponsor

Devyser Inc.

Enrollment

400 participants

Start Date

Nov 14, 2025

Study Type

OBSERVATIONAL

Conditions

Kidney Transplant Kidney Disease Transplant Recipient Renal Function

Summary

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

Min Age: 18 Years

Inclusion Criteria5

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 Criteria6

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)