Observational Study for Kidney Transplant Patients

This study is collecting blood samples and information from kidney transplant patients. The goal is to develop a new, non-invasive test that can detect donor-derived cell-free DNA (dd-cfDNA) in your blood. This DNA comes from your transplanted kidney and can help doctors check on the health of your new organ. You can join if you are 18 or older, have had a kidney transplant, and are having a biopsy because your doctor thinks it's needed. We are looking for 400 participants to help with this research. The main goal is to see if we can detect dd-cfDNA from your blood samples, measured 18 months after the samples are collected.

Study design
This is an observational study, meaning researchers will collect information and samples without giving any new treatments. It plans to enroll 400 participants.
What's involved
You would provide a whole blood sample and clinical information at the time of your indication biopsy, before the biopsy procedure. Leftover genetic samples from your kidney donor will also be collected.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, detection of donor-derived cell-free DNA, is measured at 18 months.

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NCT07006831

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

Recruiting
Not specifiedAges 18+Observational
Devyser Inc.
~400 participants
Updated 2026-08-21 on ClinicalTrials.gov

At a glance

Recruiting sites
5 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Detection of donor-derived cell-free DNA (dd-cfDNA) from whole blood
Measured over 18 months
Kidney Disease
Kidney Transplant
Transplant Recipient
Renal Function
Cell-free DNA
NGS
6 sites across 5 states
California2
Georgia1
Maryland1
Massachusetts1
Utah1

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  • Detection of donor-derived cell-free DNA (dd-cfDNA) from whole blood18 months

    Collected samples will be used for research and development of a noninvasive in- vitro diagnostic test to detect donor-derived cell-free DNA (dd-cfDNA) in kidney transplant patients.