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NCT Number: NCT07060716

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

The goal of this observational study is to learn if the donor-derived cell-free DNA (dd-cfDNA) test can assess rejection in kidney transplant recipients. Participants will have blood and urine collected at their study visit.

Researchers will compare results of the GraftAssureDx to rejection detected by standard-of-care graft biopsies.

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Key information

Conditions

Kidney Transplant Rejection Cell-free DNA

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Immunology - Transplantation Immunology, Heidelberg, Baden-Wurttemberg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject is 18 years of age or older
  • At least 12 calendar days have elapsed since the subject received a kidney transplant.
  • Subject has provided legally effective informed consent
  • Subject agrees to comply with all study procedures

Exclusion criteria

  • Kidney donor is an identical twin of the subject.
  • The subject has another previously transplanted organ in situ.
  • Subject has received a hematopoietic stem cell transplant.
  • Subject has received a bone marrow graft.
  • Subject has self-reported as pregnant.
  • In the opinion of the investigator, the subject's participation in the study would pose a risk to data integrity or to the subject's safety and welfare.

Sample Inclusion Criteria:

  • A graft biopsy is obtained within ±1 week of blood draw.
  • If blood draw is obtained after biopsy, blood draw should be taken at least 2 days after an uncomplicated biopsy procedure.

Sample Exclusion Criteria:

  • Sample collected from someone that had an invasive graft biopsy ≤ 48 hours prior to blood draw.
  • Sample collected from subject that received immunosuppressive treatment for biopsy-proven acute rejection ≤ 30 days prior to blood draw
  • Sample collected from subject that received a blood transfusion ≤ 30 days prior to blood draw.
  • Sample collected from a subject that provided another sample for the study within the past 7 days.

Treatment and study plan

donor-derived cell-free DNA test

Diagnostic Test

A donor-derived cell-free DNA (dd-cfDNA) test used to measure the concentration of total cell-free DNA and the fractional abundance of the dd-cfDNA.

Primary outcomes

  1. Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejection

    Time frame: 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.

    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.

  2. Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejection

    Time frame: Samples 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.

  3. Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejection

    Time frame: Samples 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.

  4. Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejection

    Time frame: Samples 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%.

  5. Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejection

    Time frame: Samples 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%.

Secondary outcomes

  1. ROC-AUC of dd-cfDNA vs. biopsy-confirmed rejection.

    Time frame: This testing will occur from assay cutoff up to 24 weeks after acquisition of the samples.

    The second endpoint is for investigational use only and therefore has no predefined success criteria.

  2. Correlation between GraftAssureDx results and traditional biomarkers of kidney rejection (creatinine, estimated glomerular filtration rate, blood urea nitrogen).

    Time frame: This testing will occur from assay cutoff up to 24 weeks after acquisition of the samples.

    The second endpoint is for investigational use only and therefore has no predefined success criteria.

Study contacts

Contact information is provided by the study sponsor or research team.

Ekkehard Schuetz, MD, PhD

CONTACT

[email protected]

615-927-1528

Robert Rogers, M.S.

CONTACT

[email protected]

14436258427

Sponsors and collaborators

Lead sponsor

Insight Molecular Diagnostics

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 11, 2025
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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