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

Recruiting

• Conditions: Kidney Transplant Rejection; Cell-free DNA

• Registration Number: NCT07060716
• Lead Sponsor: Insight Molecular Diagnostics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-02
• Study First Submitted QC: 2025-07-01
• Study First Posted: 2025-07-11
• Status Verified: 2025-08
• Study Start: 2025-08-22
• Last Update Submitted: 2025-08-28
• Last Update Posted: 2025-08-29
• Primary Completion: 2025-11
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

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

Exclusion Criteria

1. Kidney donor is an identical twin of the subject.
2. The subject has another previously transplanted organ in situ.
3. Subject has received a hematopoietic stem cell transplant.
4. Subject has received a bone marrow graft.
5. Subject has self-reported as pregnant.
6. 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:

1. 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:

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical validation of the dd-cfDNA test when compared to biopsy-confirmed rejection	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 Outcome Measures

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

Trial Locations

Locations (10)

University of Southern California Keck School of Medicine; 🇺🇸 Los Angeles, California, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Institute of Immunology - Transplantation Immunology; 🇩🇪 Heidelberg, Baden-Wurttemberg, Germany

Charite Universitatsmedizin; 🇩🇪 Berlin, Germany

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Baylor, Scott & White Research Institute; 🇺🇸 Dallas, Texas, United States

Intermountain Health; 🇺🇸 Murray, Utah, United States