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

NCT07060716 | Recruiting FDA Device

• 1 other identifier: CLN-001
• Study Type: observational
• Target: 125
• Locations: 2 countries
• Sites: 10

Brief Summary

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.

Conditions

Kidney Transplant Rejection; Cell-free DNA

Outcome Measures

Primary Outcomes (5)

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

  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.

  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.

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

  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.

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

  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.

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

  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%.

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

  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%.

  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.

Secondary Outcomes (2)

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

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

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

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

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals who have received a kidney transplant at centers in the United States and Germany will be invited to participate.

You may qualify if:

• 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

You may not qualify if:

• 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.
• \. 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 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.

Sponsors & Collaborators

• Insight Molecular Diagnostics: lead

Study Sites (10)

University of Southern California Keck School of Medicine

Los Angeles, California, 90033, United States

ACTIVE NOT RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

RECRUITING

Tampa General Hospital

Tampa, Florida, 33606, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

ACTIVE NOT RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Baylor, Scott & White Research Institute

Dallas, Texas, 75246, United States

RECRUITING

Intermountain Health

Murray, Utah, 84107, United States

RECRUITING

Institute of Immunology - Transplantation Immunology

Heidelberg, Baden-Wurttemberg, 69120, Germany

ACTIVE NOT RECRUITING

Charite Universitatsmedizin

Berlin, 10117, Germany

ACTIVE NOT RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma and urine

Study Officials

• Ekkehard Schuetz, MD, PhD

  Insight Molecular Diagnostics

  STUDY CHAIR

Central Study Contacts

Robert Rogers, M.S.

CONTACT

14436258427; rrogers@imdxinc.com

Ekkehard Schuetz, MD, PhD

CONTACT

615-927-1528; eschuetz@imdxinc.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: July 11, 2025
• Study Start: September 8, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 1, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

DE (2); US (8)