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Observational Study of Donor-Derived Cell-Free DNA for Kidney Transplant Monitoring

This observational study is looking at a diagnostic test called donor-derived cell-free DNA (dd-cfDNA) to see if it can help detect rejection in people who have received a kidney transplant. Researchers want to compare the results of the dd-cfDNA test to traditional kidney biopsies (where a small piece of tissue is removed for examination) to see how well the test works. You might be able to join if you are 18 or older, received a kidney transplant at least 12 days ago, and agree to follow study procedures. The study aims to enroll about 125 participants. The current recruitment status is unclear.

Study design
This is an observational study aiming to enroll about 125 participants. It is designed to compare the results of a new diagnostic test with standard biopsy results.
What's involved
You would have blood and urine collected at your study visit. The study will analyze samples collected from enrollment up to 24 weeks after they are acquired.
Compensation
Not stated in the trial record.
Follow-up
Samples will be analyzed for clinical performance from enrollment up to 24 weeks after they are acquired.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07060716

Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring

Recruiting
Not specifiedAges 18+Observational
Insight Molecular Diagnostics
~125 participants
Updated 2025-11-19 on ClinicalTrials.gov
What's tested:donor-derived cell-free DNA test

At a glance

Recruiting sites
6 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejection
Measured over 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.
+4 more outcomes measured

Conditions

Kidney Transplant Rejection
Cell-free DNA

Explore related trials

Kidney Transplantation

Where it's being run

10 sites across 9 states
Florida2
California1
Ohio1
Pennsylvania1
Tennessee1
Texas1
Utah1
Baden-Wurttemberg1

Study leadership

  • Ekkehard Schuetz, MD, PhD · STUDY_CHAIR · Insight Molecular Diagnostics

Who to contact

Robert Rogers, M.S.
[email protected]
14436258427
Email the study team

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Eligibility criteria

Inclusion

If blood draw is obtained after biopsy, blood draw should be taken at least 2 days after an uncomplicated biopsy procedure.

What this trial measures

  • Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejectionSamples 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.

  • Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejectionSamples tested after the final assay cutoffs have been established will be analyzed to demonstrate clinical performance of the investigational assay. This testing will occur from enrollment to 24 weeks after acquisition of the samples.

    Clinical sensitivity of the dd-cfDNA test shall be better or equal to published values (≥56%). Current literature shows an average sensitivity of 69% with a SD of 13%. Therefore, 56% represents the lower boundary (average - 1SD) of the distribution of published values.

  • Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejectionSamples tested after the assay final cutoffs have been established will be analyzed to demonstrate clinical performance of the investigational assay. This testing will occur from enrollment to 24 weeks after acquisition of the samples.

    Clinical Specificity of the dd-cfDNA test shall be better or equal to published values (≥75%). Current literature shows an average specificity of 81% with a SD of 6%. Therefore, 75% represents the lower boundary (average - 1SD) of the distribution of published values.

  • Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejectionSamples tested after the final assay cutoffs have been established will be analyzed to demonstrate clinical performance of the investigational assay. This testing will occur from enrollment to 24 weeks after acquisition of the samples.

    Predictive values are mathematically derived from sensitivity and specificity using the Bayes' theorem. Therefore, success criteria are defined as the lower boundary of the current literature at any given a priori probability. E.g., for an a priori probability of 20%, the lower boundary for NPV is 85%.

  • Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejectionSamples tested after the final assay cutoffs have been established will be analyzed to demonstrate clinical performance of the investigational assay. This testing will occur from enrollment to 24 weeks after acquisition of the samples.

    Predictive values are mathematically derived from sensitivity and specificity using the Bayes' theorem. Therefore, success criteria are defined as the lower boundary of the current literature at any given a priori probability. E.g., for an a priori probability of 20%, the lower boundary for Positive Predictive Value (PPV) is 49%.